Méthodes de Dissolution FDA

Dissolution Methods
Drug Name
Dosage Form
USP Apparatus
Speed (RPMs)
Medium
Volume (mL)
Recommended Sampling Date Times Updated (minutes)
Abacavir Sulfate Abacavir Sulfate/Lamivudine
Tablet Tablet
II (Paddle) 75 II (Paddle) 75 II (Paddle) 75
0.1 N HCl 0.1 N HCl 0.1 N HCl
900 900 900
Abacavir Tablet Sulfate/Lamivudine/Zidovudin e Abiraterone Acetate Tablet
5, 10, 15, and 30 10, 20, 30, and 45 5, 10, 15, 30 and 45
03/22/2 006 01/03/2 007 01/03/2 007
II (Paddle) 50
Acamprosate Calcium
Tablet (Delayed I (Basket) Release)
180
0.25% SLS in 900 56.5 mM phosphate buffer, pH 4.5 Acid Stage: 0.1 1000 N HCl Buffer Stage: "Citratesodium hydroxide" buffer pH 6.8 (150 ml of 2N NaOH, 21.014 gm of citric acid and ultra-pure water
10, 20, 30, 45 02/28/2 and 60 013
120 (Acid) 30, 12/20/2 60, 90, 120, 005 and 180 (buffer)
Dissolution Methods
Acarbose Acetaminophen Acetaminophen Tablet Suppository Tablet (Extended Release) Tablet Tablet Capsule Capsule Tablet Tablet Tablet I (Basket) 100 II (Paddle) 50 I (Basket) 100 II (Paddle) 75 II (Paddle) 50 to 1000 ml) (Method B) Water (deaerated) Phosphate buffer, pH 5 Refer to USP 900 900 10, 15, 20, 30 and 45 15, 30, 45, 60 and 90 03/22/2 006 08/17/2 006 03/03/2 011
Acetaminophen/Butalbital Acetaminophen/Butalbital/Caff eine Acetaminophen/Butalbital/Caff eine/Codeine Phosphate Acetaminophen/Caffeine/Dihy drocodeine Bitartrate Acetaminophen/Caffeine/Dihy drocodeine Bitartrate Acetaminophen/Hydrocodone Bitartrate Acetaminophen/Oxycodone
II (Paddle) 50
Water (deaerated) Refer to USP Water (deaerated) Water Water Refer to USP Refer to USP Water (deaerated) Refer to USP
900
900 900 900
II (Paddle) 50
Acetaminophen/Pentazocine Tablet HCl Acetaminophen/Propoxyphen Tablet
900
15, 30, 45, 60 01/03/2 and 90 007 01/14/2 008 10, 20, 30, 45 03/04/2 and 60 006 10, 20, 30, 45 01/03/2 and 60 007 10, 15, 30, 45 07/25/2 and 60 007 07/25/2 007 01/14/2 008 10, 20, 30, 45 01/12/2 and 60 004 01/15/2
Dissolution Methods
e HCl Acetaminophen/Propoxyphen Tablet e Napsylate Acetaminophen/Tramadol HCl Tablet Acetazolamide Capsule (Extended Release) Tablet Tablet Capsule II (Paddle) 50 II (Paddle) 50 Refer to USP II (Paddle) 50 II (Paddle) 75 0.1 N HCl 900 5, 10, 15, 20 and 30 1, 2, 5, 7, 9, 12 and 14 hours 010 01/15/2 010 03/04/2 006 01/15/2 010
Acetazolamide Acetazolomide Acitretin
Acetate Buffer, 900 pH 4.5 with 2.2% Tween 20 Refer to USP Refer to USP Refer to USP 0.01 N HCl 0.1 N HCl Refer to USP Refer to USP 900 900
Acrivastine/Pseudoephedrine Capsule HCl Acyclovir Suspension Acyclovir Acyclovir Adefovir Dipivoxil Albendazole Capsule Tablet Tablet Tablet
II (Paddle) 50
0.01 N HCl Refer to USP
600
07/21/2 011 07/14/2 008 09/22/2 011 5, 10, 15 and 01/12/2 30 004 10, 20, 30, 45 02/20/2 and 60 004 01/05/2 012 06/18/2 007 10, 20, 30, 45 04/10/2 and 60 008 08/15/2 013
Dissolution Methods
Albuterol Sulfate Tablet (Extended Release) Tablet Tablet Tablet II (Paddle) 50 0.1 N HCl 900 1, 2, 4, 6, 9 04/09/2 and 12 hours 007
Albuterol Sulfate Alendronate Sodium Alendronate Sodium/Cholecalciferol
Alfuzosin HCl
Aliskiren Hemifumarate
Tablet (Extended Release) Tablet
09/03/2 008 Refer to USP 01/14/2 008 II (Paddle) For For Alendronate: For 10, 15, 20, 30 11/25/2 Alendronate: Deaerated Alendronate: and 45 008 50; For Water; For 900; For Cholecalcifero Cholecalciferol: Cholecalcifero l: 75 0.3% SDS in l: 500 USP Water II (Paddle) 100 0.01 N HCl 900 1, 2, 12, 20 06/18/2 hours 007 I (Basket) I (Basket) 100 100 0.01 N HCl 0.01 N HCl, pH 2.0 0.01 N HCl 500 500 10, 20, 30 and 45 10, 15, 20, 30 and 45 09/03/2 008 06/07/2 012
Refer to USP
Aliskiren Tablet Hemifumarate/Amlodipine Besylate Aliskiren Tablet Hemifumarate/Amlodipine Besylate/Hydrochlorothiazide Aliskiren Tablet Hemifumarate/Hydrochlorothia zide
I (Basket)
100
900
10, 15, 20, 30 06/07/2 and 45 012 10, 15, 20, 30 10/08/2 and 45 009
I (Basket)
100
0.1 N HCl
900
Dissolution Methods
Aliskiren Hemifumarate/Valsartan Allopurinol Almotriptan Malate Alosetron HCl Tablet Tablet Tablet Tablet II (Paddle) 50 I (Basket) 100 Phosphate Buffer, pH 6.8 Refer to USP 0.1 N HCl 1000 5, 10, 15, 20, 12/23/2 30 and 45 010 07/25/2 007 5, 10, 15, and 01/20/2 30 006 10, 20, 30 01/26/2 and 45 006 2, 5, 10, 15 and 20 10/06/2 008
900 500
Alprazolam
Tablet (Orally Disintegrating)
Alprazolam
Alprazolam Altretamine Alvimopan Amantadine HCl Amantadine HCl Ambrisentan
Tablet (Extended Release) Tablet Capsule Capsule Tablet Capsule Tablet
II (Paddle) 50 (for 1 mg) Water & 75 (for 0.5 (deaerated) mg) II (Paddle) 50 70 mM Potassium Phosphate Buffer, pH 6.0 I (Basket) 100 1% Phosphate Buffer, pH 6.0 Refer to USP Refer to USP II (Paddle 50 0.1 N HCl Water (deaerated) Refer to USP 0.05 M Acetate
500
500
1, 4, 8, 12 02/08/2 and 16 hours 007 06/18/2 007 01/29/2 010 5, 10, 15, 20, 10/21/2 30 and 45 010 10, 20, 30, 45 01/12/2 and 60 004 12/23/2 010 5, 10, 15, 30, 05/20/2
900 500
II (Paddle) 50
II (Paddle) 75
900
Dissolution Methods
Amiloride HCl Amiloride HCl/Hydrochlorothiazide Aminosalicylic Tablet Tablet Granule (Delayed Release) II (Paddle) 100 Buffer, pH 5.0 Refer to USP Refer to USP Acid Stage: 0.1 1000 N HCl; Buffer Stage 2: pH 7.5 Phosphate Buffer 1% SLS in 1000 water Acetate Buffer, 900 pH 4.0, with 1% Tween 80 Refer to USP 0.01 N HCl 0.01 M HCl Phosphate Buffer, pH 6.8 0.01 N HCl Phosphate 500 500 900 500 900 and 45 009 06/07/2 012 06/07/2 012 Acid Stage: 2 07/14/2 hours; Buffer 008 Stage: 1, 2, 3 and 4 hours 10, 20, 30, 45, 60 and 90 10, 20, 30, 45, 60 and 90 01/12/2 004 01/12/2 004 01/14/2 008 01/14/2 004 10/06/2 008 04/02/2 009 06/20/2 007 07/21/2
Amiodarone HCl (Test 1)
Tablet
II (Paddle) 100
Amiodarone HCl (Test 2)
Tablet
I (Basket)
50
Amitriptyline HCl Amlodipine Besylate Amlodipine Besylate
Tablet Tablet Tablet (Orally Disintegrating) Tablet II (Paddle) 75 II (Paddle) 50 II (Paddle) 75 I (Basket) II 100 50
Amlodipine Besylate/Atorvastatin Calcium Amlodipine Capsule Besylate/Benazepril HCl Amlodipine Tablet
10, 20, 30, 45 and 60 5, 10, 15 and 20 5, 10, 15 and 30 10, 20 , 30, 45, and 60 5, 10, 15, 20,
Dissolution Methods
Besylate/Hydrochlorothiazide/ Olmesartan Medoxomil Amlodipine Besylate/Hydrochlorothiazide/ Valsartan Amlodipine Besylate/Hydrochlorothiazide/ Valsartan (10/25/320 mg) Amlodipine Besylate/Olmesartan Medoxomil Amlodipine Besylate/Telmisartan (Paddle) Tablet II (Paddle) II (Paddle) 50 Buffer, pH 6.8 Phosphate Buffer, pH 6.8 Phosphate Buffer, pH 6.8 Phosphate Buffer, pH 6.8 Telmisartan: Phosphate Buffer, pH 7.5; Amlodipine: 0.01N HCl, pH 2 Phosphate Buffer, pH 6.8 3 Stage dissolution: 50 mM potassium phosphate monobasic buffer at pH 4.0 (0-2 hours), 6.0 (2-4 hours) and 6.8 ( 4 hours 900 30 and 45 10, 20, 30 and 45 10, 20, 30 and 45 10, 20, 30 and 45 Telmisartan: 10, 15, 20, 30 and 45; Amlodipine: 10, 15, 20, 30 and 45 5, 10, 15, 20, 30 and 45 0.25, 0.5, 1, 2, 2.25, 2.5, 3, 4, 4.25, 4.5, 5 and 6 hours 011 03/25/2 010 03/25/2 010 08/11/2 008 08/05/2 010
Tablet
55
900
Tablet
II (Paddle) 50
900
Tablet
II (Paddle) 75
Telmisartan: 900; Amlodipine: 500
Amlodipine Besylate/Valsartan Amoxicillin
Tablet Tablet (Extended Release)
II (Paddle) II (Paddle
75 100
1000 900
07/21/2 011 10/21/2 010
Dissolution Methods
Amoxicillin Amoxicillin Amoxicillin Capsule Tablet and beyond) Refer to USP Refer to USP Water 900 (degassed) Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Lansoprazole DelayedRelease Capsules Refer to USP for monographs of Amoxicillin Capsules, Clarithromycin Tablets and Omeprazole DelayedRelease Capsules Refer to USP As 01/31/2 013 01/31/2 013 5, 10, 15, 20, 06/06/2 30 and 45 013 02/28/2 013
For Oral II (Paddle) 50 Suspension Amoxicillin/Clarithromycin/Lan Capsule/Tablet/ soprazole Capsule (Copackage)
Amoxicillin/Clarithromycin/Om Capsule/Tablet/ eprazole Capsule (Copackage)
02/28/2 013
Amoxicillin/Clavulanate
Tablet
0, 0.5, 1, 2, 3, 10/04/2
Dissolution Methods
Potassium Amoxicillin/Clavulanate Potassium Amoxicillin/Clavulanate Potassium Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetami ne Sulfate Amphetamine Aspartate/Amphetamine Sulfate/Dextroamphetamine Saccharate/Dextroamphetami ne Sulfate Suspension Tablet (Chewable) Tablet II (Paddle) 75 Water (deaerated) Refer to USP Deionized Water appropriate 900 4 and 5 012 hours 5, 10, 15 and 01/14/2 30 004 01/14/2 008 10, 20, 30 11/25/2 and 45 008
I (Basket)
100
500
Capsule (Extended Release)
II (Paddle) 50
Amphetamine ER
Capsule
II (Paddle) 50
Dilute HCl, pH 0-2 hrs: 750 1.1 for first 2 hrs, mL. After 2 then add 200 mL hrs: 950 mL of 200 mM Phosphate Buffer and adjust to pH 6.0 for the remainder 750 ml of dilute 750 ml of HCl, pH 1.1 for dilute HCl, the first 2 hours, 200 ml of then add 200 ml phosphate of 200 mM buffer phosphate buffer, and adjust to pH 6
0.5, 1, 2, 3, and 4 hours
07/25/2 007
1, 2, 3, 4, and 08/17/2 6 hours 006
Dissolution Methods
(w/ HCl or NaOH) for the remainder Water (deaerated) 0.1 N HCl 0.1 N HCl Water 0.05 M Sodium Phosphate Buffer with 0.05% SLS, pH 6.8 2.2% sodium dodecyl sulfate in distilled water pH 1.2 USP Buffer (Hydrochloric Acid) Acetate Buffer, pH 4.0 0.1 N HCl
Ampicillin/Ampicillin Trihydrate for Oral Suspension Amprenavir Capsule Anagrelide HCl Anastrozole Apixaban Tablets Capsule Tablet Tablet
II (Paddle) 25 II (Paddle) 50 I (Basket) 100
900 900 900 900 900
5, 10, 15, 20
II (Paddle) 50 II (Paddle) 75
01/03/2 007 10, 15, 30, 02/19/2 and 45 008 5, 10, 15, 30 01/14/2 and 45 004 5, 10, 15, and 01/03/2 30 and 45 007 5, 10, 20, 30 05/09/2 and 45 013
Aprepitant
Capsule
II (Paddle) 100
900
10, 15, 20, 30 01/20/2 and 45 006 10, 20, 30 and 45 12/20/2 005
Aripiprazole
Tablet
II (Paddle) 60
900
Aripiprazole Armodafinil
Tablet (Orally Disintegrating) Tablet
1000 900
10, 20, 30 and 45 10, 20, 30 and 45
08/11/2 008 01/14/2 008
Dissolution Methods
Asenapine Maleate Aspirin/Butalbital/Caffeine Aspirin/Butalbital/Caffeine Tablet (Sublingual) Capsule Tablet II (Paddle) 50 Acetate Buffer, pH 4.5 Refer to USP Refer to USP Refer to USP I (Basket) I (Basket) 75 100 Water (deaerated) 0.01 N HCl for first hour, 0.1 M Phosphate Buffer, pH 5.5, thereafter Acetate Buffer, pH 4.5 Water (deaerated) Water (deaerated) Refer to USP II (Paddle) 50 0.025 N HCl 1000 900 0-1 hrs: 900 mL. 900 mL thereafter 500 1, 2, 3, 4 and 05/09/2 5 013 06/24/2 010 06/24/2 010 08/27/2 009 10, 20, 30, 45 01/15/2 and 60 004 Acid: 10, 20, 10/09/2 30, 45 and 60 007 min; Buffer:1, 2, 5, and 7 hrs 10, 20, 30, 01/15/2 45, 60 and 004 90 10, 20, 30, 01/15/2 45, 60 and 004 90 10, 20, 30, 01/15/2 45, 60 and 004 90 01/15/2 010 10, 20, 30 01/20/2
Aspirin/Butalbital/Caffeine/Co Capsule deine Phosphate Aspirin/Caffeine/Orphenadrine Tablet Citrate Aspirin/Dipyridamole Capsule
Aspirin/Hydrocodone Bitartrate Aspirin/Meprobamate
Tablet
II (Paddle) 75
900
Tablet
I (Basket)
100
900
Aspirin/Methocarbamol
Tablet
II (Paddle) 50
900
Aspirin/Oxycodone HCl Atazanavir Sulfate
Tablet Capsule
Dissolution Methods
and 45 Atenolol Atomoxetine HCl Atorvastatin Calcium Tablet Capsule Tablet II (Paddle) 50 II (Paddle) 75 Refer to USP 0.1 N HCl 0.05 M Phosphate buffer, pH 6.8 40% isopropanol buffered to pH 8.0 with potassium dihydrogen phosphate Develop a dissolution method 40% isopropranol buffered to pH 8.0 with potassium dihydrogen phosphate Water (deaerated) Develop a 1000 900 006 07/25/2 007 10, 20, 30 12/20/2 and 45 005 5, 10, 15 and 01/15/2 30 004 10, 20, 30, 45, 60 and 90 06/18/2 007
Atovaquone
Tablet
II (Paddle) 50
900
Atovaquone
Oral Suspension Tablet II (Paddle) 50 with PEAK vessels
07/21/2 009 900 15, 30, 45 and 60 08/17/2 006
Atovaquone/Proguanil HCl
Auranofin Azacitidine
Capsule Injectable
II (Paddle) 50
900
10, 20, 30, and 45
01/15/2 004 09/03/2
Dissolution Methods
Suspension Azathioprine Azilsartan Kamedoxomil Tablet Tablet II (Paddle) II (Paddle) 50 dissolution method Refer to USP Phosphate 900 Buffer, pH 7.8 (deaerated) Phosphate 900 Buffer, pH 6.8 containing 1.0% Tween 80, Phosphate 900 Buffer, pH 6.0 0.1 M Phosphate Buffer, pH 6.0 Phosphate buffer, pH 6.0 50 mM Acetate Buffer, pH 4.5 Refer to USP II (Paddle) 100 Water (degassed) 1000 900 008 04/08/2 010 5, 10, 15, 20, 05/09/2 30 and 45 013 5, 10, 15, 20, 05/09/2 30 and 45 013
Azilsartan Kamedoxomil/Chlorthalidone
Tablet
50
Azithromycin
Azithromycin
Suspension (Extended Release) Tablet
II (Paddle) 50
II (Paddle) 75
15, 30, 45, 60, 120 and 180 10, 20, 30 and 45 10, 20, 30, and 45 5, 10, 15 and 30
04/15/2 008 01/14/2 008 08/17/2 006 07/14/2 008
Azithromycin Baclofen
Oral Suspension Tablet (Orally Disintegrating) Tablet Tablet
900 500 mL (10 mg) or 1000 mL (20mg)
Baclofen Balsalazide Disodium
12/15/2 009 10, 20, 30, 07/31/2 45, 60, 75, 90 013 and 120
Dissolution Methods
Balsalazide Disodium Bedaquiline Fumarate Benazepril HCl Benazepril HCl/Hydrochlorothiazide Bendroflumethiazide/Nadolol Benzonatate Benzphetamine HCl Bepridil HCl Betamethasone Acetate/Betamethasone Sodium Phosphate Capsule Tablet Tablet Tablet Tablet Capsule Tablet Tablet Injectable Suspension II (Paddle) 50 with sinker I (Basket) 150 II (Paddle) 50 I (Basket) 100 pH 6.8 buffer 0.01N HCl Water (deaerated) 0.1 N HCl Refer to USP Refer to USP Water 0.1 N HCl 0.05% SLS, pH 3.0 or Develop an in vitro release method using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate 900 900 500 500 10, 20, 30, and 45 10, 15, 20, 30 and 45 10, 20, 30 and 45 10, 20, 30 and 45 01/26/2 006 06/06/2 013 01/16/2 004 01/16/2 004 07/25/2 007 06/20/2 007 01/16/2 004 04/08/2 010
II (Paddle) 50 I (Basket) IV (Flow through cell) 100 Flow @ 8 mL/min
900 900
10, 20 , 30, and 45 10, 20, 30, 45 and 60 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, and 360
Dissolution Methods
method, for comparative evaluation by the Agency Refer to USP II (Paddle) 50 Tier 1 Medium: 900 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 Tier 2 Medium: 0.5% HDTMA in 0.05 M phosphate buffer, pH 7.5 with 0.05 g/L pancreatin enzyme 1% SLS in 1000 water Tetracycline and 900 Metronidazole: 0.1 N HCl; Bismuth Subcitrate Potassium: Water 15, 30, 45 and 60
Bethanechol Chloride Bexarotene
Tablet Capsule
10/06/2 008 08/17/2 006
Bicalutamide
Tablet
Bismuth Subcitrate Capsule Potassium/Metronidazole/Tetr acycline HCl
10, 20, 30, 45 and 60 5, 15, 20, 30 and 45
12/15/2 005 10/06/2 008
Dissolution Methods
Bisoprolol Fumarate Tablet II (Paddle) 75 II (Paddle) 50 with sinker Refer to USP 0.1 N HCl 900 5, 10, 20, 30 and 45 10, 20, 30, 45, 60 and 75 Bisoprolol Tablet Fumarate/Hydrochlorothiazide Boceprevir Capsule 06/18/2 007 01/20/2 004 01/31/2 013
Bosentan Brinzolamide
Tablet Ophthalmic Suspension
II (Paddle)
50
Bromocriptine Mesylate Budesonide
Tablet Capsule II (Paddle) 75 with sinker
50 mM 900 phosphate buffer, pH 6.8 with 0.1% sodium dodecyl sulfate 1% SLS in 900 water Develop a method to characterize in vitro release Refer to USP Acid stage: 0.1 N HCl; Buffer stage: Phosphate Buffer, pH 7.5 Refer to USP 0.9% Sodium Chloride at Acid stage: 1000; Buffer stage: 1000
15, 30, 45 and 60
09/02/2 010 09/01/2 011
Bumetanide Buprenorphine
Tablet Film, Transdermal VI (Cylinder) 50
600
07/25/2 007 Acid stage: 2 05/20/2 hours; Buffer 009 stage: 1, 2, 4, 6 and 8 hours 07/14/2 008 0.5,1, 2, 4, 6, 05/09/2 8,12, 16 and 013
Dissolution Methods
(Extended Release) Buprenorphine HCl Tablet (Sublingual) with adapter, if needed I (Basket) 100 32C 24 hours
Water
500
Buprenorphine HCl/Naloxone Film HCl (Sublingual)
V (Paddle 100 over Disk) with 56 mm, 40 mesh stainless steel disk.
Buprenorphine HCl/Naloxone Tablet HCl (Sublingual) Bupropion HCl Tablet (Extended Release) Tablet
I (Basket)
100
Acetate Buffer, 900 pH 4.0 (12.5mM Sodium acetate trihydrate and 60mM glacial acetic acid. Adjust the pH with glacial acetic acid or ammonium hydroxide). Water 500
2, 5, 8, 10, 15, and until at least 80% of the labeled content is dissolved 1, 2, 3, 5, 7 and 10
04/09/2 007
10/31/2 013
1, 3, 5, 7.5, 10, 15 and 20
07/01/2 010 07/25/2 007 08/15/2 013
Refer to USP
Bupropion HCl
Refer to USP
Dissolution Methods
Bupropion Hydrobromide Tablet (Extended Release) Tablet Tablet Tablet Capsule I (Basket) 75 0.1N HCl 900 1, 2, 4, 6, 8 06/10/2 and 10 hours 009 07/21/2 009 5, 10, 15 and 07/14/2 30 008 5, 10, 15 and 01/20/2 30 004 06/03/2 008 5, 10, 15, 20 and 30 07/21/2 009 01/14/2 008 10, 20, 30, 45 06/20/2 and 60 007
Buspirone Hydrochloride Busulfan Cabergoline Calcitriol
Refer to USP II (Paddle) 50 II (Paddle) 50 Water (Deaerated) 0.1 N HCl Develop a quantitative rupture test Water Refer to USP II (Paddle) 50 0.35% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 0.70% Polysorbate 20 in 0.05 M Phosphate Buffer, pH 6.5 0.35% 900 500 500
Calcium Acetate Calcium Acetate
Capsule Tablet
II (Paddle)
50
900
Candesartan Cilexetil (16 mg, Tablet 8 mg and 4 mg)
Candesartan Cilexetil (32 mg) Tablet
II (Paddle) 50
900
10, 20, 30, 45 06/20/2 and 60 007
Candesartan
Tablet
II (Paddle) 50
900
10, 20, 30, 45 01/29/2
Dissolution Methods
Cilexetil/Hydrochlorothiazide (16/12.5 mg) Candesartan Cilexetil/Hydrochlorothiazide (32/12.5 mg and 32/25 mg) Capecitabine Carbamazepine Carbamazepine Carbamazepine Carbamazepine Tablet II (Paddle) 50 Polysorbate 20 in phosphate buffer pH 6.5 0.70% Polysorbate 20 in phosphate buffer pH 6.5 Water (deaerated) Water (deaerated) Refer to USP 1% SLS in Water Refer to USP and 60 010
900
15, 20, 30, 45 01/29/2 and 60 010
Tablet Suspension Tablet Tablet (Chewable) Tablet (Extended Release) Capsule (Extended Release)
900 900
10, 20, 30 and 45 10, 20, 30, 45 and 60
01/23/2 004 01/20/2 004
II (Paddle
75
900
15, 30, 45, 60 12/23/2 and 90 010 01/14/2 008 09/01/2 011
Carbamazepine
II (Paddle) 75
Carbidopa/Entacapone/Levod Tablet
I (Basket)
Carbidopa
First 4 hours: Dilute Acid, pH 1.1. After 4 hours: Phosphate Buffer, pH 7.5 with 0.1% sodium lauryl sulfate (SLS). For both
First 4 h: 900. 1, 2, 4, 6, 8, After 4 h: 10 and 12 900 hours
Carbidopa
10, 20, 30, 45 01/03/2
Dissolution Methods
opa and Levodopa: 50; Entacapone: 125 Carbidopa and Levodopa: 0.1 N HCl, For Entacapone: Phosphate buffer pH 5.5 0.1 N HCl and Levodopa: 750 ml. Entacapone: 900 ml 900 and 60 007
Carbidopa/Levodopa
Carbidopa/Levodopa Carbidopa/Levodopa Carglumic Acid
Tablet (Extended Release) Tablet (Orally Disintegrating) Tablet Tablet
II (Paddle) 50
II (Paddle) 50
0.1 N HCl Refer to USP
750
0.5, 0.75, 1, 1.5, 2, 2.5, 3 and 4 hours 5, 10, 15, 30, and 45
08/15/2 013 07/25/2 007 01/14/2 008 08/15/2 013 01/29/2 010
II (Paddle) 100
Carisoprodol Carvedilol Carvedilol Carvedilol Phosphate
Tablet Tablet Tablet Capsule (Extended Release) Capsule (Extended Release)
0.05M Phosphate Buffer, pH 6.8 Refer to USP Refer to USP SGF without enzyme 0.1 N HCl
750
5, 10, 15, 20 and 30
900 900
10, 20, 30 and 45 1, 4, 8, 12, 18 and 24 hours
01/21/2 004 04/02/2 009
Carvedilol Phosphate
II (Paddle) 100
0.1N HCl
900
1, 2, 4, 6, 8, 10/31/2 12, 18 and 24 013 hours
Dissolution Methods
Cefaclor Cefaclor Cefaclor Capsule Tablet (Chewable) Tablet (Extended Release) Tablet Capsule Suspension Capsule Suspension II (Paddle) 25 II (Paddle) 50 II (Paddle) 50 Refer to USP Refer to USP Refer to USP 03/03/2 011 03/03/2 011 03/03/2 011 09/02/2 010 09/02/2 010 07/25/2 007 07/25/2 007 04/09/2 007 01/15/2 010 04/09/2 007
Cefadroxil Cefadroxil Cefadroxil Cefdinir Cefdinir
Refer to USP Refer to USP Water Phosphate Buffer, pH 6.8 0.05 M Phosphate buffer, pH 6.8 Simulated Gastric Fluid without enzyme 0.05 M Phosphate buffer, pH 7.2 0.05 M Phosphate Buffer, pH 7.2 900 900 900 5, 10, 15, 30 and 45 5, 10, 15, 30 and 45 10, 20, 30 and 45 5, 10, 15, 20 and 30 10, 20, 30 and 45
Cefditoren Pivoxil
Tablet
II (Paddle) 75
900
Cefixime
Suspension
II (Paddle) 50
900
Cefixime
Capsule
I (Basket)
100
900
10, 20, 30, 45 08/15/2 and 60 013
Dissolution Methods
Cefixime Cefixime Cefpodoxime Proxetil Cefpodoxime Proxetil Cefprozil Cefprozil Cefprozil Cefprozil Monohydrate Ceftibuten Dihydrate Tablet Tablet (Chewable) Suspension Tablet Tablet Tablet For Oral Suspension Suspension Suspension II (Paddle) 25 II (Paddle) 25 II (Paddle) 50 II (Paddle 25 Refer to USP Phosphate 900 Buffer, pH 7.2 Glycine Buffer 900 (0.04 M) pH 3.0 Refer to USP Refer to USP Refer to USP Water Water (deaerated) 0.05 M Phosphate Buffer, pH 7.0 Refer to USP Tier 1 Medium: 0.04 M tribasic sodium phosphate (pH 12) with 1% SLS. Tier 2 900 900 1000 12/23/2 010 10, 15, 20, 12/23/2 30, and 45 010 10, 20, 30 12/20/2 and 45 005 07/25/2 007 07/25/2 007 10/04/2 012 5, 10, 15, 20 10/04/2 and 30 012 5, 10, 15 and 01/21/2 30 004 10, 20, 30 01/21/2 and 45 004 07/25/2 007 10, 20, 30, 45 07/01/2 and 60 010
II (Paddle) 50
Cefuroxime Axetil Celecoxib
Tablet Capsule II (Paddle) 50 mg, 100 mg and 200 mg: 50 rpm; 400 mg: 75 rpm
Tier 1: 1000 mL Tier 2: 750 mL (initial) 1000 mL (final)
Dissolution Methods
Initial Medium: 750 mL of simulated gastric fluid, USP (includes pepsin); At 20 minutes, while stirring, add 180 mL of appropriate concentrations of SLS solution (for a final concentration of 1% SLS). Add about 70 mL of 1.2 N NaOH to adjust the pH to 12. Water 900 Refer to USP Water (deaerated) 0.1 N HCl 900 500
Cephalexin Cephalexin Cetirizine HCL Cetirizine HCl/Pseudoephedrine HCl
Suspension Capsule
II (Paddle) 25
Tablet (Regular II (Paddle) 50 & Chewable) Tablet I (Basket) 100 (Extended Release)
5, 10, 20, and 07/25/2 30 007 04/02/2 009 10, 20, 30 03/04/2 and 45 006 0.17, 0.25, 06/18/2 0.5, 1, 2, 6 007 and 8 hours
Dissolution Methods
Cevimeline HCL Capsule II (Paddle) 50 with option to use a sinker II (Paddle) 75 III 27 dpm (Reciprocat ing Cylinder) 0.1N HCl 900 5, 10, 15, and 01/26/2 30 006
Chlorambucil Chlorpheniramine Maleate
Tablet Tablet (Extended Release)
0.1N HCl Row 1: Test Fluid 1 (0.1N HCl) for 1st hour. Row 2: Test fluid 2 (Phosphate Buffer, pH 7.5) for 5th hour 0.05 M Phosphate Buffer, pH 6.5 Simulated Gastric Fluid (SGF) at 37C 0.5C Simulated Intestinal Fluid without enzyme Refer to USP Refer to USP
900 Row 1: 250 mL. Row 2: 250 mL
10, 20, 30, and 45 1 hour for test fluid 1, and 4 hours for test fluid 2
08/17/2 006 07/25/2 007
Chlorpheniramine Maleate/Ibuprofen/Pseudoeph edrine HCl Chlorpheniramine Polistirex/Hydrocodone Polistirex Chlorpheniramine Polistirex/Hydrocodone Polistirex Chlorpromazine HCl Chlorthalidone
Tablet
II (Paddle) 50
900
10, 20, 30 and 45
02/20/2 004
Extended Release Oral Suspension Capsule (Extended Release) Tablet Tablet
II (Paddle)
50
495
1, 2, 3, 6, 8, 06/30/2 12, 16 and 24 011 hours 1, 4, 12, and 24 hours 11/25/2 008 01/05/2 012 04/15/2
II (Paddle) 50
500
Dissolution Methods
Chlorzoxazone Choline Fenofibrate Tablet Capsule (Delayed Release) II (Paddle) 50 Refer to USP Acid Stage: 0.05M Sodium Phosphate, pH 3.5 0.05; Buffer Stage: 0.05 M Sodium Phosphate, pH 6.8 0.05 Develop a method to characterize in vitro release 0.3% SLS in water 0.05 N HCl Acid stage: 500; Buffer stage: 900 Acid stage: 120; Buffer stage: 15, 30, 60, 90, 120, 240 and 360 008 01/14/2 008 07/01/2 010
Ciclopirox
Topical Suspension
03/25/2 010
Cilostazol Cinacalcet HCl Ciprofloxacin
Tablet Tablet Oral suspension
900 900
Ciprofloxacin HCl
Tablet
0.05 M Acetate 900 Buffer with 0.025% Brij35 (polyoxyethylene lauryl ether), pH 4.5 Refer to USP
15, 30, 45, 60 and 90 10, 20, 30 and 45 10, 20, 30 and 45
08/17/2 006 01/26/2 006 03/25/2 010
09/02/2 010
Dissolution Methods
Ciprofloxacin HCl Tablet (Extended Release) Otic Suspension I (Basket) 100 0.1 N HCl 900 1, 2, 4, and 7 01/14/2 hours or until 008 at least 80% released 09/01/2 011
Ciprofloxacin HCl/Hydrocortisone
Ciprofloxacin/Ciprofloxacin HCl (AB) Citalopram HBr Citalopram Hydrobromide Clarithromycin
Tablet (Extended Release) Tablet Capsule Tablet (Extended Release) Tablet Suspension
II (Paddle) 50
Develop a method to characterize in vitro release 0.1 N HCl
900
15, 30, 60, and 120
01/14/2 008 01/14/2 008 10/06/2 008 10/06/2 008
Refer to USP II (Paddle) 50 0.1 N HCl Refer to USP 900 900 10, 20, 30 and 45
Clarithromycin Clarithromycin
Refer to USP II (Paddle) 50 0.05 M Phosphate Buffer, pH 6.8 Refer to USP 0.1N HCl (degassed) 900
07/25/2 007 10, 20, 30, 45 01/23/2 and 60 004 09/01/2 011 10, 20, 30, 45 10/31/2 and 60 013
Clindamycin HCl Clobazam
Capsule Tablet II (Paddle) 75
900
Dissolution Methods
Clobazam Clobazam Clobazam Clomiphene Citrate Clonazepam Clonazepam Clonidine Clonidine ( 0.1 mg) Oral Suspension Tablet Oral Suspension Tablet Tablet (Orally Disintegrating) Tablet Transdermal Tablet (Extended Release) II (Paddle) 50 with sinker II (Paddle) 75 II (Paddle) 75 II (Paddle) 75 0.1N HCl (degassed) 0.1 N HCl (degassed) 0.1 N HCl (degassed) Refer to USP Water Refer to USP Refer to USP Acid stage: 0.01 Acid stage: N HCl; Buffer 500; Buffer stage: stage: 500 Phosphate Buffer, pH 7.0 500 mL 0.1N HCl for the 1st hour, then add 400 mL 0.27M Sodium Phosphate (Dibasic) buffer Acid stage: 500; Buffer stage: 900 900 900 900 5, 10, 15, 20 and 30 5, 10, 20, 30, 45 and 60 5, 10, 15, 20, 25 and 30 10/31/2 013 07/31/2 013 07/31/2 013 08/15/2 013 5, 10, 15, 30, 07/25/2 and 45 007 04/08/2 010 02/18/2 009 Acid stage: 1 01/26/2 and 2 hours; 012 Buffer stage: 1, 2, 4, 6, 10, 14 and 16 hours 1, 2, 3, 6, 9, 07/01/2 12, 16, 20 010 and 24 hours
II (Paddle) 50
900
Clonidine ( EQ. 0.17 mg and EQ. 0.26 mg)
Tablet (Extended Release)
II (Paddle)
50
Dissolution Methods
Clonidine HCl Clopidogrel Bisulfate Clorazepate Dipotassium Clotrimazole Clotrimazole Clozapine Tablet Tablet Tablet Lozenge Tablet (Vaginal) II (Paddle) 50 Tablet (Orally Disintegrating) II (Paddle solution Refer to USP Refer to USP Refer to USP Refer to USP 0.1 N HCl 900 900 06/18/2 007 07/25/2 007 01/31/2 013 10/06/2 008 10, 20, 30 01/24/2 and 45 004 5, 10, 15, 20, 06/09/2 and 30 011
Clozapine Codeine Sulfate Colchicine Colesevelam HCl
Tablet Tablet Tablet Tablet
50 RPM (12.5 pH 4.5 Acetate mg, 25 mg Buffer and 100 mg); 75 RPM (150 mg and 200 mg) Refer to USP Refer to USP Refer to USP Disintegration Testing as per USP <701> in various media
07/21/2 011 09/01/2 011 08/05/2 010 10/28/2 010
Dissolution Methods
such as deionized water, simulated gastric fluid and simulated intestinal fluid. 0.1 N HCl 900
Cyclobenzaprine
Cyclobenzaprine HCl Cyclophosphamide Cycloserine
Capsule (Extended Release) Tablet Tablet Capsule
II (Paddle) 50
2, 4, 6, 8, 12, 09/03/2 and 16 hours 008 07/25/2 007 10, 20, 30, 45 01/24/2 and 60 004 05/09/2 013 10, 20, 30, 01/14/2 45, 60 and 008 90
Refer to USP I (Basket) 100 Water (deaerated) Refer to USP 900
Cyclosporine (100 mg) (AB1) Capsule (Liquid II (Paddle) 75 filled)
Cyclosporine (25 mg) (AB1)
Capsule (Liquid II (Paddle) 75 filled)
0.1 N HCl 1000 containing 4 mg of N,Ndimethydodecyla mine-N-oxide per mL 0.1 N HCl 500 containing 4 mg of N,Ndimethydodecyla mine-N-oxide per mL
10, 20, 30, 45, 60 and 90
01/14/2 008
Dissolution Methods
Cysteamine Bitartrate Capsule I (Basket) 75 0.1 N HCl 0.01 N HCl (pH 2.0) 900 900 Dabigatran Etexilate Mesylate Capsule I 100 (Basket) fo r 75 strength: I (Basket with modified diameter of 24.5 mm) for 150 mg strength: II (Paddle) 50 10, 20, 30 and 45 10, 20, 30, and 45 01/24/2 004 09/22/2 011
Dalfampridine
Danazol Dantrolene Sodium
Tablet (Extended Release) Capsule Capsule
Phosphate Buffer, pH 6.8 Refer to USP
900
I (Basket)
100
Dapsone Darifenacin Hydrobromide
Tablet Tablet (Extended Release) I (Basket) 100
0.5% Hyamine 900 10X in water, adjust to pH 6.8 with 0.1 N KOH or 0.1 N HCl Refer to USP 0.01M HCl 900 Comparative dissolution data
0.5, 1, 2, 4, 6, 06/07/2 8, 10 and 12 012 hours 06/18/2 007 10, 20, 30, 40 01/27/2 and 60 004
12/23/2 010 1, 4, 8, 12, 01/20/2 16, 20 and 24 006 hours
Dissolution Methods
should also be provided in 900 ml pH 4.5 buffer, pH 6.8 buffer, and water using Apparatus I (Basket) at 100 RPM. 2% Tween-20 in 0.05 M Sodium Phosphate Buffer, pH 3.0 pH 4.0 Acetate buffer containing 1% Triton X-100 Phosphate buffer pH 6.8 with 0.5% Tween 20 0.05 M Phosphate Buffer, pH 6.0 containing 0.6% w/v SDS Refer to USP Refer to USP
Darunavir Ethanolate
Tablet
II (Paddle) 75
900
10, 20, 30, and 45
09/13/2 007
Dasatinib
Tablet
II (Paddle) 60
1000
10, 15, 30 and 45 10, 20, 30 and 45
10/30/2 009 06/21/2 006
Deferasirox
Tablet (for Oral Suspension)
II (Paddle) 50
900
Delavirdine Mesylate
Tablet
II (Paddle) 50
900
10, 20, 30, 45 12/03/2 and 60 007
Demeclocycline HCl Demeclocycline HCl
Capsule Tablet
07/25/2 007 07/25/2 007
Dissolution Methods
Desipramine HCl Desloratadine Desloratadine Tablet Tablet (Orally Disintegrating) Tablet II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 Refer to USP 0.1 N HCl 0.1 N HCl 900 500 01/31/2 013 3, 6, 10, 15 06/18/2 007 15, 20, 30 03/04/2 and 45 006 For 04/02/2 Desloratadine 009 : 10, 20, 30 and 45; For Pseudoephed rine Sulfate: 1, 2, 6 and 8 hours For 04/02/2 Desloratadine 009 : 10, 20, 30 and 45; For Pseudoephed rine Sulfate: 1, 2, 4, 8, 16 and 24 hours 10, 20, 30 12/15/2 and 45 005 11/04/2 008 1, 2, 4, 8, 12, 04/02/2
Desloratadine/Pseudoephedri Tablet ne Sulfate (2.5 mg/120 mg) (Extended Release)
First hour: 0.1 N 1000 HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5
Desloratadine/Pseudoephedri Tablet ne Sulfate (5 mg/240 mg) (Extended Release)
II (Paddle) 50
First hour: 0.1 N 1000 HCl; After 1 hour: 0.1M Potassium Phosphate Buffer pH 7.5
Desmopressin Acetate Desogestrel/Ethinyl Estradiol Desvenlafaxine Succinate
Tablet Tablet Tablet
II (Paddle) 75
Water (deaerated) Refer to USP 0.9% NaCl in
500
I (Basket)
100
900
Dissolution Methods
Dexamethasone (Extended Release) Implant (Intravitreal) water VII (with 30 cycles per reciprocati min ng 50 mesh baskets) Phosphate 30 Buffered Saline containing 0.05 g/L sodium dodecyl sulfate at 45 0.5C Refer to USP Develop a method to characterize in vitro release Acid Stage: 0.1 Acid stage: N HCl, Buffer 500; Buffer Stage: pH 7.0 stage: 900 Phosphate Buffer with 5 mM SLS First 2 hours: Acid: 500, 0.01 N HCl, Buffer: 500 Hours 2-10: Phosphate Buffer, pH 6.8 Water 900 16, 20 and 24 009 hours 12, 24, 48, 10/21/2 72, 96, 120, 010 144, 168, 192, 216 and 24 hours 04/02/2 009 04/02/2 009
Dexamethasone Dexamethasone/Tobramycin
Tablet Ophthalmic Suspension
Dexlansoprazole
Capsule (Delayed Release)
I (Basket)
100
Dexmethylphenidate HCl
Capsule (Extended Release)
I (Basket)
100
Acid stage: 120; Buffer Stage: 10, 20, 40, 50, 60 , 75, 105 and 120 0.5, 1, 2, 4, 6, and 10 hours
08/05/2 010
01/14/2 008
Dexmethylphenidate HCl
Tablet
I (Basket)
100
10, 15, 30, and 45
06/18/2 007
Dissolution Methods
Dextroamphetamine Sulfate Capsule (Extended Release) Tablet Tablet (Extended Release) Capsule I ( Basket) 100 0.1 N HCl 500 1, 4, 8 and 12 11/25/2 hours 008 10, 20, 30, 45 and 60 1, 2, 6, and 12 hours 5, 10, 15, 20 and 30 01/31/2 013 11/25/2 008 01/05/2 012
Dextroamphetamine Sulfate Dextromethophan HBr/Guaifenesin Dextromethorphan Hydrobromide/Quinidine Sulfate Dextromethorphan Polistirex
I (Basket) I (Basket)
100 50
Water 0.01 N HCl
500 900
I (Basket)
100
Diazepam
Suspension (Extended Release) Gel (Rectal)
II (Paddle) 50
pH 1.2, 900 Simulated Gastric Fluid without enzyme 0.1 N HCl 500
30, 60, 90 and 180 5, 10, 15, 30 and 45
10/06/2 008 04/02/2 009 07/25/2 007
II (Paddle) 50
Diazepam Diazoxide
Tablet Oral Suspension Topical patch V (Paddle 50 over Disk) with a watchdish
0.05 M Phosphate Buffer, pH 6.8 Refer to USP
500
Diclofenac Epolamine
Develop a dissolution method pH 6.8 500 phosphate buffer at 32 0.5C
15, 30, 45, 60, 90, 120 and 180
10/21/2 010
Dissolution Methods
Diclofenac Potassium Powder for Oral Solution (a diameter of 6 cm) II (Paddle 75 0.05M 400 phosphate buffer (TriSodium Phosphate Dodecahydrate in 0.1 N HCl and pH adjusted to 6.8) 50 mM 900 Phosphate buffer pH 6.8 SIF without 900 enzyme Refer to USP 2.5, 5, 7.5 and 10 10/21/2 010
Diclofenac Potassium
Capsule
II (Paddle
50
10, 15, 20, 30 10/21/2 and 45 010 10, 20, 30, 45, 60 and 90 01/27/2 004 06/10/2 009 06/10/2 009 Diclo.: 120 12/15/2 (acid) 15, 30, 005 45 and 60 (Buffer). Miso:10, 20 and 30
Diclofenac Potassium
Tablet
II (Paddle) 50
Diclofenac Sodium
Diclofenac Sodium Diclofenac Sodium/Misoprostol Enteric Coated
Tablet (Extended Release) Tablet (Delayed Release) Tablet (Delayed II (Paddle) 100 (diclo) 50 Release) (diclo) II (miso) (Paddle) (miso)
Refer to USP Diclofenac: Acid Diclo: Acid: Stage: 0.1 N HCl 750 Buffer Stage: Buffer:1000 750ml 0.1N Miso: 500 HCL+250ml 0.2M phos.buffer, pH
Dissolution Methods
6.8 (Method A) Misoprostol: Water (deaerated) Refer to USP II (Paddle) 75 I (Basket) 100 Water (deaerated) Acid stage: 0.1 N HCl; Buffer stage: 0.1 N HCl:0.2M Tribasic Sodium Phosphate (3:1), pH 6.8 0.4% SLS in water Water (deaerated) Refer to USP Refer to USP II (Paddle) 100 Phosphate Buffer, pH 5.8 900 2, 8, 14, and 24 hours 900 1000 10, 20, 30 and 45 Acid stage: 60, 90 and 120; Buffer stage: 10, 20, 30, 45 and 60 10, 15, 20, 30 and 45 1, 3, 5, 7 and 9 hours
Dicloxacillin Sodium Didanosine Didanosine
Capsule Tablet (Chewable) Capsule (Delayed Release Pellets)
06/18/2 007 01/26/2 004 01/26/2 004
Dienogest/Estradiol Valerate Diethylpropion HCl
Tablet Tablet (Extended Release) Tablet Tablet Tablet (Extended Release)
II (Paddle) 50 I (Basket) 100
900 900
06/07/2 012 05/20/2 009 04/15/2 008 06/18/2 007 02/19/2 008
Diflunisal Digoxin Diltiazem HCl
Dissolution Methods
Diltiazem HCl (AB2) Capsule (Extended Release) Capsule (Extended Release) Capsule (Extended Release) Vaginal Insert (Extended Release) Vaginal Suppository Refer to USP 02/19/2 008 02/19/2 008 02/19/2 008 500 0.25, 0.5, 1, 09/01/2 2, 2.5, 3, 3.5, 011 4 and 5 hours 10/04/2 012
Diltiazem HCl (AB3)
Refer to USP
Diltiazem HCl (AB4)
Refer to USP
Dinoprostone
II (Paddle) 50
Deionized Water
Dinoprostone
Diphenhydramine Citrate/Ibuprofen Diphenhydramine HCl/Ibuprofen Dipyridamole Disopyramide Phosphate
Tablet
II (Paddle) 50
Capsule
I (Basket)
100
Tablet Capsule (Extended
Develop a method to characterize in vitro release 50 mM Phosphate Buffer, pH 6.5 200 mM Phosphate Buffer, pH 7.2 Refer to USP Refer to USP
900
10, 20, 30 and 45 10, 20, 30 and 45
01/14/2 008 01/14/2 008 06/18/2 007 11/04/2 008
900
Dissolution Methods
Disopyramide Phosphate Disulfiram Release) Capsule Tablet II (Paddle) 100 Refer to USP 2% SDS 900 15, 30, 45, 60, 75, 90, 105, and 120 09/03/2 008 06/18/2 007
Divalproex Sodium Divalproex sodium
Tablet (Delayed Release) Tablet II (Extended (Paddle) Release)
Refer to USP 100 Acid phase: 0.1 N HCl for 45 minutes; Drug Release: (after 45 minutes) 0.05 M Phosphate Buffer with 75 mM SDS, pH 5.5 0.05 M Phosphate Buffer, pH 7.5 0.001 M HCL Refer to USP Acid phase:500 mL; Drug release: 900 mL
07/25/2 007 1.5, 3, 6, 9, 10/28/2 12, 15, 18, 21 010 and 24 hours
Divalproex Sodium
Dofetilide Dolasetron Mesylate Donepezil HCl
Capsule II (Paddle) 50 (Delayed Release Pellet) Capsule I (Basket) 100 Tablet Tablet (Orally Disintegrating (ODT)) II (Paddle) 50
500
2, 4, 6, 8 and 10/06/2 10 hrs 008 10, 15, 30 and 45 01/20/2 006 07/01/2 010 03/04/2 006
900
0.1 N HCl
900
10, 20, 30 and 45
Dissolution Methods
Donepezil HCl Donepezil HCl (23 mg) Tablet Tablet II (Paddle) 50 II (Paddle 50 0.1 N HCl 0.05 M Phosphate Buffer, pH 6.8 0.01 N HCl SGF without enzyme 900 900 10, 20, 30 and 40 1, 2, 3, 4, 6, 8 and 10 hours 10, 20, 30, 45 and 60 1, 2, 4, 6, 8, 12 and 16 hours 5, 10, 15, 20, 30 and 45 01/27/2 004 12/23/2 010 01/27/2 004 01/03/2 007 09/02/2 010
Doxazosin Mesylate Doxazosin Mesylate
Tablet Tablet (Extended Release) Tablet
900 900
Doxepin HCl
II (Paddle) 50
Doxepin HCl Doxercalciferol
Capsule Capsule
Simulated 900 Gastric Fluid w/o enzyme (pH 1.11.3) Refer to USP Develop a quantitative rupture test Develop a method to characterize in vitro release, starting at pH 6.00 0.05 and at 47C 0.5C. Replicate for 12
08/05/2 010 06/03/2 008 10/04/2 012
Doxorubicin HCl
Injectable (Liposomal)
Dissolution Methods
Doxycycline Capsule (Delayed Release) II (Paddle) 75 dosage vials. Dilute HCl, pH 1.1 for 2 hours and then add 200 mL of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 6.0 using 2 N HCl and/or 2N NaOH 0.01 N HCl 0.01 N HCl Acid stage: 750; Buffer stage: 950 1, 2, 2.5 , 3 and 4 hours 10/06/2 008
Doxycycline Doxycycline Doxycycline Hyclate
Suspension Tablet
II (Paddle) 25 II (Paddle) 75 50
900 900
Tablet (Delayed I (Basket) Release)
Doxycycline Hyclate Dronabinol
Capsule Capsule II (Paddle) 100 and 150
Acid stage: 0.06 Acid stage: N HCl; Buffer 900; Buffer stage: stage: 1000 Neutralized Phthalate Buffer, pH 5.5 Refer to USP 10% Labrasol in 500 Water; (In addition, the USP capsule rupture test
5, 10, 15 and 20 15, 30, 45, 60 and 90 Acid stage: 5, 10, 15, 20 and 30; Buffer stage: 10, 20, 30 and 45
09/03/2 008 01/14/2 008 04/02/2 009
07/14/2 008 5, 10, 15, 30, 01/31/2 45, 60, and 007 until at least 80% of the labeled
Dissolution Methods
Dronedarone HCl Tablet II (Paddle) 75 should also be conducted) pH 4.5 Phosphate buffer Water Water 1000 content is released 10, 15, 20, 30, 45, 60, 90 and 120 10, 20, 30, and 45 10, 20, 30, and 45 5, 10, 15, 20, 30 and 45 08/05/2 010 01/03/2 007 09/22/2 011 01/05/2 012
Drospirenone/Estradiol
Tablet
900 900
Drospirenone/Ethinyl Estradiol Tablet Drospirenone/Ethinyl Estradiol/Levomefolate Calcium Tablet
Duloxetine HCl
Capsule (Delayed Release Pellets)
I (Basket)
100
Dutasteride
Capsule (SoftGelatin)
II (Paddle)
50
Phosphate 900 Buffered Saline pH 6.8 containing 0.03% ascorbic acid [A] Gastric 1000 Challenge: 0.1N HCl [B] Buffer Medium: pH 6.8 phosphate buffer (USP) Tier I: 900 Dissolution Medium: 0.1 N HCI with 2% (w/v) sodium dodecyl sulfate (SDS) (900 mL)
120 minutes (For A) 15, 30, 45, 60 and 90 minutes (For B) 15, 30, 45 and 60
03/22/2 006
08/05/2 010
Dissolution Methods
Tier II: Dissolution Medium: 0.1 N HCI with pepsin (as per USP) (450 mL) for the first 25 minutes, followed by addition of 0.1 N HCI with SDS (4% w/v) (450 mL) for the remainder of the dissolution test. Dutasteride::Tier I: Dissolution Medium: 1%w/v cetyltrimethylam monium bromide (CTAB) in 0.1 N HCl. Tier II: Dissolution Medium: 1% w/v CTAB in 0.1 N HCl with 0.16% w/v pepsin. TamsulosinAcid Stage (0-2 hrs): 0.1 N HCl.
Dutasteride/Tamsulosin HCl
Capsule
Dutasteride Dutasteride: : II 75 (Paddle) Tamsulosin: with sinker. 50 Tamsulosin : II (Paddle)
Dutasteride: 900. Tamsulosin: Acid stage: 750; Buffer stage: 1000
Dutasteride: 01/26/2 15, 30, 45 012 and 60 minutes. Tamsulosin: Acid Stage: 2 hours Buffer stage: 0.5, 1, 2, 3, 5, 7 and 10 hours
Dissolution Methods
Buffer stage: Add 250 mL of 0.2 M Sodium Phosphate Tribasic, Dodecahydrate pH 6.8 1% Sodium 900 Lauryl Sulfate in water
Efavirenz
Capsule
Efavirenz
Tablet
II (Paddle) 50 A sinker may be used with justification if necessary. II (Paddle) 50 II (Paddle) 100
15, 30, 45 and 60
03/22/2 006
Efavirenz 600 mg; Tablet Emtricitabine 200 mg; Tenofovir Disoproxil Fumarate 300 mg Eletriptan Hydrobromide Tablet Eltrombopag Olamine Tablet
2% SLS in water 2% SLS in water
1000 1000
10, 15, 30, 45, 60 10, 20, 30, and 45
06/18/2 007 01/03/2 007
I (Basket)
100
0.1 N HCl
900
II (Paddle) 50
Emtricitabine
Capsule
II (Paddle) 50
0.5% 900 Polysorbate 80 in Phosphate Buffer, pH 6.8 Tier 1: 0.1 N HCl 900 Tier 2: 0.1 N HCl
5, 10, 15 and 30 10, 15, 20, 30, 45, and 60 10, 20, 30 and 45
04/02/2 009 06/07/2 012
12/16/2 005
Dissolution Methods
containing Pepsin 750,000 USP units/L. Tier 2 is used after failure of Tier 1 testing 0.01 N HCl 900 Refer to USP II (Paddle) 50 II (Paddle) 50 Phosphate Buffer, pH 5.5 Phosphate buffer pH 6.8 (50mM) 0.1 N HCl 0.2 M Phosphate Buffer, pH 7.5 0.2 M Phosphate Buffer, pH 7.5 0.5 N NaOH with 10% Triton-X100 0.1 N HCl 900 1000 10, 20, 30 and 45 10, 20, 30, and 45 10, 20, 30 and 45 15, 30, 45 and 60 10, 20, 30 and 45
Emtricitabine/Tenofovir Disoproxil Fumarate Enalapril Maleate Entacapone Entecavir
Tablet Tablet Tablet Tablet
II (Paddle) 50
5, 10, 15, 30 and 45
01/03/2 007 09/03/2 008 01/29/2 004 06/21/2 006 12/19/2 005 07/14/2 008 02/19/2 008
Eplerenone Eprosartan Mesylate
Tablet Tablet
1000 1000
Eprosartan Tablet Mesylate/Hydrochlorothiazide Ergocalciferol Capsule
II (Paddle) 75
1000
II (Paddle) 100
500
15, 30, 45, 60 08/05/2 and 90 010 15, 30, 45 03/22/2
Erlotinib HCl
Tablet
II (Paddle) 75
1000
Dissolution Methods
Erythromycin Erythromycin Ethylsuccinate Tablet (Delayed Release) Suspension II (Paddle) 75 containing 1% SDS Refer to USP Monobasic Sodium Phosphate, pH 6.8 Buffer with 1% SLS Buffer w/ 1% SLS Develop a dissolution method 0.1 N HCl 0.1 N HCl Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8 Acid stage: 0.1 N HCl; Buffer stage: Sodium Phosphate Buffer, pH 6.8 900 and 60 006 10/31/2 013 10, 20, 30, 45 01/27/2 and 60 004
Erythromycin Ethylsuccinate/Sulfisoxazole Acetyl Escitalopram Oxalate Escitalopram Oxalate Esomeprazole Magnesium
Granules for Oral suspension Capsule Tablet Capsule (Delayed Release Pellets) For Oral Suspension (Delayed Release)
09/02/2 010 900 900 Acid stage: 300; Buffer stage: 1000 10, 20, 30 and 45 10, 20, 30 and 45 Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 Acid stage: 120; Buffer stage: 10, 20, 30, 45 and 60 10/06/2 008 02/20/2 004 02/26/2 004
Esomeprazole Magnesium
II (Paddle
100
Acid stage: 300; Buffer stage: 1000
09/02/2 010
Dissolution Methods
Estazolam Esterified Estrogens Tablet Tablet II (Paddle) 50 II (Paddle) 50 Water (deaerated) Water 900 900 10, 20, 30 and 45 15, 30, 45, 60, 90, 120 and 180 1, 2, 3, 5, 8, 10 and 12 hours 1, 9, 16, 17, 18, 19, 45 days 01/27/2 004 02/19/2 008 07/21/2 009 01/03/2 007 10/28/2 010
Estradiol
Vaginal Tablet
I (Basket)
40
Estradiol
Vaginal Ring
Incubator shaker
130
Phosphate 500 Buffer, pH 4.75 0.05 0.9% Saline 250
Estradiol (0.014 mg/24 hr)
Film, Transdermal (Extended Release) Estradiol (0.025 mg/24 hr, Film, 0.0375 mg/24 hr, 0.05 mg/24 Transdermal hr, 0.06 mg/24 hr, 0.075 (Extended mg/24 hr and 0.1 mg/24 hr) Release) Estradiol (Test 1) (0.025 Film, mg/24 hr, 0.0375 mg/24 hr, Transdermal 0.05 mg/24 hr, 0.075 mg/24 hr (Extended and 0.1 mg/24 hr) Release)
VI 50 (Cylinder) attach the patch to a disk at the bottom of the cylinder
Develop a method to characterize in vitro release Develop a method to characterize in vitro release Water at 32 0.5C
10/28/2 010
0.025 mg/24 1, 2, 4, 6, 8, hr and 0.0375 10 and 12 mg/24 hr: 500 hours mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL
10/28/2 010
Dissolution Methods
Estradiol (Test 2) (0.05 mg/24 Film, hr and 0.1 mg/24 hr) Transdermal (Extended Release) Estradiol (Test 3) 0.0375 mg/24 hr, 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr) Film, Transdermal (Extended Release) V (Paddle 50 over Disk) with a stainless steel disk VI 50 (Cylinder) attach the patch to the cylinder wit h doublesided tape Water at 32 0.5C 900 6, 12, 18, 24, 10/28/2 36, 48, 60, 72 010 and 96 hours
Water at 32 0.5C
0.0375 mg/24 hr: 500 mL; 0.05 mg/24 hr, 0.075 mg/24 hr and 0.1 mg/24 hr: 900 mL
1, 2, 4, 6, 10, 10/31/2 12, 18, 24 013 and 36 hours
Estradiol/Norethindrone Acetate Estradiol/Norgestimate (1mg/0.09mg) Estramustine Phosphate Sodium Estrogens Conjugated Synthetic A Estrogens, Conjugated Synthetic B Eszopiclone Ethacrynic Acid
Tablet Tablet Capsule Tablet II (Paddle) 50 I (Basket) I (Basket) 100 50
Refer to USP 0.3% SLS in water Water Water 500 900 900 10, 20, 30 and 45 10, 20, 30 and 45 1, 2, 3, 5, 8, 10 and 12 hours 2, 5, 8 and 12 hours 10, 20, 30 and 45
01/05/2 012 07/09/2 004 07/15/2 009 09/02/2 010 10/06/2 008 09/13/2 007 12/23/2
Water 0.1 N HCl Refer to USP
900 500
Dissolution Methods
Ethambutol HCl Ethinyl Estradiol Ethinyl Estradiol/Ethynodiol Diacetate Tablet Tablet Tablet II (Paddle) 75 Refer to USP Refer to USP 0.25% Sodium Lauryl Sulfate (SLS) in Water Develop a method to characterize in vitro release Refer to USP Refer to USP Refer to USP 600 10, 20, 30 and 45 010 01/14/2 008 09/22/2 011 07/14/2 008 01/31/2 013
Ethinyl Estradiol/Etonogestrel Vaginal Ring
Ethinyl Estradiol/Levonorgestrel Ethinyl Estradiol/Levonorgestrel (AB) Ethinyl Estradiol/Levonorgestrel (AB2) Ethinyl Estradiol/Norethindrone Ethinyl Estradiol/Norethindrone Ethinyl Estradiol/Norethindrone Acetate
02/19/2 008 02/19/2 008 11/04/2 008 10, 20, 30 and 45 01/14/2 008 07/15/2 009 07/15/2 009
Tablet (Chewable) Tablet Tablet
II (Paddle) 75
0.09% Sodium 500 Lauryl Sulfate in 0.1 N HCl Refer to USP Refer to USP
Dissolution Methods
Ethinyl Estradiol/Norgestimate Tablet Ethinyl Estradiol/Norgestimate Tablet (AB) Ethinyl Estradiol/Norgestrel Tablet II (Paddle) 75 II (Paddle) 75 II (Paddle) 75 0.05% Tween 20 600 in water 0.05% Tween 20 600 in water Water with 5 500 ppm of Tween 80 0.1% 900 Hydroxypropylbetacyclodextrin at 32 C 0.1N HCl 900 Refer to USP Refer to USP Refer to USP 5, 10, 20 and 30 10, 20, 30 and 45 10, 20, 30, 45, 60 and 90 0.25, 0.5, 1, 2, 4, 8, 12, 16, 20 and 24 hours 01/14/2 008 01/14/2 008 01/28/2 004 05/20/2 009
Ethinyl Estradiol; Norelgestromin
Film, Transdermal
Modified 50 USP Type V (Paddleover-disk) I (Basket) 75
Ethionamide Ethosuximide Etidronate Disodium Etodolac
Tablet Capsule Tablet Tablet (Extended Release) Tablet Capsule Tablet
10, 20, 30, 45 01/31/2 and 60 013 04/15/2 008 06/18/2 007 06/24/2 010 01/14/2 008 06/24/2 010 06/30/2 011
Etodolac Etoposide Etravirine (100 mg)
Refer to USP Refer to USP II (Paddle) 50 1.0 % Sodium lauryl sulfate 500 (phase 1): 900 Phase 1: No Sampling.
Dissolution Methods
(SLS) in 0.01 M HCl in two phases: Phase 1: 500 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 400 mL of 2.25% SLS in 0.01 M HCl. 1.0 % Sodium lauryl sulfate (SLS) in 0.01 M HCl in two phases: Phase 1: 1000 mL of degassed 0.01 M HCl for 10 minutes. Phase 2: Add 800 mL of 2.25% SLS in 0.01 M HCl. Water with 0.4% sodium dodecylsulfate 0.5%(w/v) SLS Solution 0.45% SLS in (phase 2) Phase 2: 5, 10, 20, 30, 45, 60 and 90
Etravirine (200 mg)
Tablet
II (Paddle)
70
1000 (phase 1): 1800 (phase 2)
Phase 1: No Sampling. Phase 2: 5, 10, 20, 30, 45, 60 and 90
06/30/2 011
Everolimus
Tablet
II (Paddle) I (Basket)
50
500
10, 20, 30 and 45 10, 20, 30 and 45 10, 20, 30
07/01/2 010 08/17/2 006 01/14/2
Exemestane Ezetimibe
Tablet Tablet
100
900 500
II (Paddle) 50
Dissolution Methods
Ezetimibe/Simvastatin Tablet II (Paddle) 50 0.05 M Acetate Buffer, pH 4.5 0.01M Sodium Phosphate, pH 7.0/0.5% SDS 0.01 N HCl 0.1 N HCl 0.1 M Phosphate buffer, pH 4.5 Refer to USP 0.1 M Phosphate Buffer, pH 4.5 0.1 M Phosphate Buffer, pH 4.5 Develop a dissolution method 0.05 M Phosphate Buffer, pH 7.2 0.05 M and 45 900 008 5, 10, 20 and 01/03/2 30 007 5, 10, 15, 20 and 30 10, 20, 30 and 45 10, 15, 30 and 45 08/15/2 013 04/09/2 007 11/25/2 008 06/18/2 007 10/06/2 008
Ezogabine Famciclovir Famotidine
Tablet Tablet Suspension
II (Paddle) 75 II (Paddle) 50 II (Paddle) 25 and 50
1000 900 900
Famotidine Famotidine
Tablet Tablet (Orally Disintegrating) Tablet (Chewable) Tablet (Chewable) Tablet II (Paddle) 50 II (Paddle) 50
900
2, 5, 10, 15 and 20
Famotidine
II (Paddle) 50
900
10, 20, 30, 45 01/29/2 and 60 004 12/15/2 009
Famotidine/Calcium Carbonate/Magnesium Hydroxide Famotidine/Ibuprofen
900
5, 10, 15, 20, 08/15/2 30 and 45 013 5, 10, 15, 20 08/15/2
Febuxostat
Tablet
II (Paddle) 75
900
Dissolution Methods
Felbamate Felbamate Felodipine Suspension Tablet Tablet (Extended Release) Capsule (Micronized) Capsule II (Paddle) 50 Phosphate Buffer, pH 6.0 Water (deaerated) Refer to USP Refer to USP and 30 900 013 5, 10, 15 and 01/28/2 30 004 08/15/2 013 01/14/2 008 10, 20, 30, 40 and 60 15, 30, 45, 60, 90 and 120 06/03/2 008 02/19/2 008
Fenofibrate Fenofibrate
Fenofibrate (40 mg and 120 mg) Fenofibrate (48 mg and 145 mg) Fenofibrate (54 mg and 160 mg) Fenofibric Acid
Tablet
II (Paddle
75
Tablet
II (Paddle
50
Tablet
II (Paddle
50
Tablet
II (Paddle) 75
0.025 M SLS in 1000 water Phosphate 900 Buffer w/ 2% Tween 80 and 0.1% pancreatin, pH 6.8 0.75% Sodium 900 lauryl sulfate in water 25 mM Sodium 1000 lauryl sulfate in water 0.05 M Sodium 1000 lauryl sulfate in water Phosphate 900 buffer, pH 6.8
5, 10, 20, 30, 10/21/2 45 and 60 010 5, 10, 20, 30, 10/21/2 45 and 60 010 5, 10, 20, 30, 10/21/2 45 and 60 010 5, 15, 30, 45 and 60 08/05/2 010
Dissolution Methods
Fenoprofen Calcium Fentanyl Capsule Transdermal VII 30 cycles per (Reciprocat minute. ing holder)- amplitude of cylinder. about 2m. Refer to USP Equimolar mixture of 0.005 M phosphoric acid solution, and 0.005 M sodium phosphate, monobasic monohydrate (pH ~ 2.6). at 32 C. Change the test samples into fresh preequilibrated release medium at the time points indicated. Remove the protective liner and place the film onto a piece of nylon netting with adhesive facing the net. Secure the netting and transdermal 250 mL for the 75 and 100 mcg/hr, 200 mL for the 50 mcg/hr and 150 mL for the 25 and 12.5 mcg/hr dosage strength. 11/25/2 008 0.5, 1, 2, 4 06/09/2 and 24 hours 011
Dissolution Methods
system using nylon tie wraps at the top and bottom of the cylinder on the holder. The adhesive side faces towards the media. 0.1M Phosphate 500 Buffer, pH 4.5 Phosphate 500 Buffer, pH 6.8 Phosphate 100 Buffered Saline solution, pH 7.0
Fentanyl Citrate Fentanyl Citrate Fentanyl Citrate (0.1 mg and 0.4 mg)
Lozenges Tablet (Sublingual) Tablet (Buccal)
II (Paddle) 175 II (Paddle) 50 II (Paddle) 100 small volume dissolution apparatus II (Paddle) 100 small volume dissolution apparatus I 100 (Basket) 10 0 mL dissolution vessel
5, 10, 20, 30 and 40 1, 3, 5, 7, 10, 15 and 20 3, 5, 7.5, 10, 15 and 20
05/20/2 009 08/15/2 013 11/20/2 009
Fentanyl Citrate (0.2 mg, 0.3 mg, 0.6 mg and 0.8 mg)
Tablet (Buccal)
Phosphate 200 Buffered Saline solution, pH 7.0
3, 5, 7.5, 10, 15 and 20
11/20/2 009
Fentanyl Citrate (0.2 mg, 0.4 mg, 0.6 mg and 0.8 mg)
Film (Buccal)
25-mM Phosphate Buffer, pH 6.4
60
5, 10, 15, 20, 12/15/2 30 and 45 009
Dissolution Methods
Fentanyl Citrate (1.2 mg) Film (Buccal) I (Basket) 100 100 mL dissolution vessel II (Paddle) 75 with sinker II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 25-mM Phosphate Buffer, pH 6.4 Phosphate Buffer, pH 6.8 0.001 M HCl 0.001 N HCl 0.001 N HCl Water (deaerated) Refer to USP 100 5, 10, 15, 20, 12/15/2 30 and 45 009
Fesoterodine Fumarate
Fexofenadine HCl Fexofenadine HCl Fexofenadine HCl Fexofenadine HCl Fexofenadine HCl/Pseudoephedrine HCl Finasteride Fingolimod
Tablet (Extended Release) Suspension Tablet (Orally Disintegrating) Tablet Capsule Tablet (Extended Release) Tablet Capsule
900
900 500 900 900
1, 2, 4, 6, 8, 10, 12, 16 and 20 hours 10, 20, 30 and 45 5, 10, 15, 30 and 45 5, 10, 20, 30 and 45 10, 20, 30, 45 and 60
08/15/2 013 11/25/2 008 09/03/2 008 02/19/2 004 01/29/2 004 04/02/2 009 07/25/2 007 08/15/2 013
Refer to USP I (Basket) 100 0.1 N HCl with 500 0.2% SDS (sodium dodecyl sulfate) 0.1 N HCl 900 Refer to USP 5, 10, 15, 20 and 30
Flavoxate HCl Flecainide Acetate
Tablet Tablet
I (Basket)
100
5, 10, 20 and 01/29/2 30 004 12/15/2
Dissolution Methods
Fluconazole Tablet II (Paddle) 50 Water (deaerated) 009 900 (For 150, 10, 20, 30, 45 03/04/2 200, 300 & and 60 006 400 mg tabs) 500 (For 50 & 100 mg tabs) 900 10, 20, 30 01/30/2 and 45 004 500 10, 20, 30 01/30/2 and 45 004 06/24/2 010 900 5, 10, 15, 20 06/07/2 and 30 012 05/20/2 009 07/25/2 007 09/02/2 010 5, 10, 15 and 01/03/2 30 007 10, 20, 30 08/17/2 and 45 006 01/31/2 013
Fluconazole (200 mg/5 mL) Fluconazole (50 mg/5 mL) Flucytosine Fludarabine Phosphate Fludrocortisone Acetate Fluoxetine
Suspension Suspension Capsule Tablet Tablet Capsules (Delayed Release) Capsule Tablet Capsule Capsule
Water (deaerated) Water (deaerated) Refer to USP Water Refer to USP Refer to USP
II (Paddle) 50
Fluoxetine HCl Fluoxetine HCl Fluoxetine/Olanzapine Flutamide
Refer to USP I (Basket) 100 0.1 N HCl 0.1 N HCl Refer to USP 1000 900
II (Paddle) 50
Dissolution Methods
Fluvastatin Sodium Fluvastatin Sodium Capsule Tablet (Extended Release) Tablet Capsule (Extended Release) Tablet I (Basket) 50 Refer to USP Water (deaerated) Water (deaerated) Phosphate Buffer, pH 6.8 1000 0.5, 2, 4, 6 and 8 hours 10, 20, 30 and 45 1, 2, 4, 6, 8 and 12 hours 10, 20, 30 and 45 01/14/2 008 09/22/2 011 01/03/2 007 01/15/2 010 12/16/2 005
Fluvoxamine Maleate Fluvoxamine Maleate
900 900
Fosamprenavir Calcium
II (Paddle) 75
Fosamprenavir Calcium Fosinopril Sodium Fosinopril Sodium/Hydrochlorothiazide Frovatriptan succinate Furosemide Gabapentin Gabapentin
Oral Suspension Tablet Tablet Tablet Tablet Tablet Capsule
250 mM Sodium 900 Acetate/Acetic acid buffer pH 3.5 10 mM HCl 900 Water (deaerated) Refer to USP Phosphate Buffer pH 5.5 Refer to USP Refer to USP Refer to USP 900
5, 10,15 and 20 10, 20, 30 and 45
II (Paddle) 50
900
5, 10, 15, 20 and 30
12/03/2 007 01/30/2 004 08/11/2 008 11/04/2 008 08/05/2 010 06/03/2 008 06/03/2
Dissolution Methods
Gabapentin Enacarbil Tablet (Extended Release) Tablet Capsule (Extended Release) II (Paddle) 50 II (Paddle) 50 008 10 mM 500 (for 300 0.5, 1, 2, 4, 6, 01/31/2 Phosphate mg); 900 (for 8, 12 and 24 013 buffer at pH 7.4 600 mg) hours with 1.0 % SLS Refer to USP 08/11/2 008 50 mM 900 1, 4, 10 and 01/20/2 potassium 12 hours 006 dihydrogen phosphate buffer pH 6.5 Comparative dissolution data should also be provided in 900 ml pH 0.1 HCl, pH 4.5 buffer, and water using Apparatus II (Paddle) at 50 RPM. Water 900 10, 20, 30, 45 02/02/2 (deaerated) and 60 004 Tween 80 (5% 1000 10, 20, 30, 45 10/28/2 v/v) in water and 60 010 Refer to USP 07/25/2 007
Galantamine HBr Galantamine HBr
Ganciclovir Gefitinib Gemfibrozil
Capsule Tablet Tablet
Dissolution Methods
Gemifloxacin Mesylate Glimepiride Glimepiride/Pioglitazone HCl Tablet Tablet Tablet II (Paddle) 50 II (Paddle) 75 II (Paddle) 75 0.01 N HCl 900 Phosphate 900 Buffer, pH 7.8 For Pioglitazone: 900 pH 2.0, HCl Buffer. For Glimepiride: pH 6.8, Sodium Phosphate Buffer with 0.2% sodium dodecyl sulfate 0.01 M HCl with 900 0.5% Sodium Dodecyl Sulfate Simulated 900 Intestinal Fluid without pancreatin, pH 7.5 Refer to USP Refer to USP II (Paddle) 50 0.05 M Phosphate 900 10, 20, 30 and 45 5, 10, 15 and 30 For Pioglitazone: 10, 15, 20, 30 and 45; For Glimepiride: 10, 15, 20 and 30 01/03/2 007 07/23/2 004 04/02/2 009
Glimepiride/Rosiglitazone Maleate Glipizide
Tablet
II (Paddle) 75
5, 10, 15, 30, 01/03/2 45 and 60 007 1, 2, 4, 8, 16 hours and until at least 80% dissolved 04/10/2 008
II (Paddle) 50
Glipizide Glipizide/Metformin HCL Glyburide (Micronized)
08/05/2 010 12/18/2 008 10, 20, 30, 45 02/02/2 and 60 004
Dissolution Methods
Glyburide (Non-micronized) Glyburide/Metformin HCl Glycopyrrolate Goserelin Acetate Tablet Tablet Tablet Implant Prior to sampling, the jar is removed from incubation and mechanical ly swirled with digital orbital shaker VI (Cylinder) Swirl orbit of 50 mm at 205 rpm for 6 seconds II (Paddle) 75 Buffer, pH 7.5 0.05 M Borate Buffer, pH 9.5 Refer to USP Refer to USP Each implant should be incubated in 50 mL of phosphate buffered saline, pH 7.4, at 39C (warmed overnight before the implants are added), in a 120-mL Wheaton jar. 80 microL /L phosphoric acid (85%) at 32 0.5C Phosphate buffer, pH 6.5 0.54% Sodium Lauryl Sulfate 50 500 10, 20, 30, 45 02/02/2 and 60 004 01/14/2 008 07/25/2 007 3, 14, 35, 56 11/04/2 and 84 days 008 (10.8 mg strength); 7, 14, 17, 21 and 28 days (3.6 mg strength)
Granisetron
Granisetron HCl Griseofulvin
Film, Transdermal (Extended Release) Tablet Oral Suspension
50
1000
2, 6, 12, 24, 03/03/2 36, 48, 60, 72 011 and 96 hours 10, 20, 30, 45 and 60 10, 20, 30 and 45 06/05/2 006 10/28/2 010
II (Paddle) 50 II (Paddle) 25 and 50
500 1000
Dissolution Methods
Griseofulvin (Microcrystalline) Oral Suspension Griseofulvin (Microcrystalline) Tablet Griseofulvin (Ultramicrocrystalline) Guaifenesin Tablet I (Basket) 75 II (Paddle) 25 and 50 (SLS) in Water 0.54% Sodium Lauryl Sulfate (SLS) in Water Refer to USP Refer to USP 0.1 N HCl 900 1000 10, 20, 30 and 45 10/28/2 010
Tablet (Extended Release) Guaifenesin/Pseudoephedrine Tablet Hydrochloride (Extended Release) Guanfacine Tablet (Extended Release) Haloperidol Tablet Homatropine Methylbromide/Hydrocodone Bitartrate Hydralazine HCl Hydrochlorothiazide Hydrochlorothiazide Tablet
01/15/2 010 11/04/2 008 1, 2, 4, 6 and 01/03/2 12 hours 007 1, 2, 6, and 12 hours 11/25/2 008
I (Basket)
50
0.01 N HCl
900
II (Paddle)
75
HCl Buffer, pH 2.2 Refer to USP Refer to USP
900
1, 2, 4, 6, 8, 07/01/2 10, 12, 16, 20 010 and 24 hours 11/25/2 008 10/30/2 009 04/10/2 008 07/25/2 007 02/03/2
Tablet Tablet Capsule I (Basket) 100
Refer to USP Refer to USP 0.1 N HCl 900 10, 20, 30
Dissolution Methods
Hydrochlorothiazide/Irbesarta Tablet n Hydrochlorothiazide/Lisinopril Tablet Hydrochlorothiazide/Losartan Tablet Potassium Hydrochlorothiazide/Metoprolo Tablet l Succinate (Extended Release) and 45 II (Paddle) 50 0.1 N HCl 1000 10, 20, 30 and 45 II (Paddle) 50 0.1 N HCl 900 10, 20, 30, 45 and 60 I (Basket) 100 Water 900 10, 20, 30, 45 (deaerated) and 60 II (Paddle) Hydrochloroth Hydrochlorothiaz Hydrochloroth Hydrochloroth iazide: 100; ide: 0.1N HCl; iazide: 500; iazide: 10, 15, Metoprolol Metoprolol Metoprolol 20, 30, and succinate: 75 succinate: succinate: 45 minutes; Phosphate 500 Metoprolol Buffer, pH 6.8 succinate: 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours Refer to USP II (Paddle) 50 II (Paddle) 50 0.1 N HCl 0.05 M Phosphate Buffer, pH 6.8 Water (deaerated) Refer to USP 900 900 004 09/24/2 008 02/03/2 004 02/03/2 004 10/31/2 013
Hydrochlorothiazide/Metoprolo Tablet l Tartrate Hydrochlorothiazide/Moexipril Tablet HCl Hydrochlorothiazide/Olmesart Tablet an Medoxomil Hydrochlorothiazide/Quinapril Tablet HCl Hydrochlorothiazide/Spironola Tablet ctone
I (Basket)
100
900
01/05/2 012 5, 10, 15 and 02/10/2 30 004 5, 10, 15, 20, 07/09/2 30, 45 and 007 60 5, 10, 20 and 02/03/2 30 004 08/27/2 009
Dissolution Methods
Hydrochlorothiazide/Telmisart Tablet an Hydrochlorothiazide/Triamtere Tablet ne Hydrochlorothiazide/Valsartan Tablet Hydrochlorothizide/Triamteren Capsule e Hydrocodone Tablet Bitartrate/Ibuprofen Hydrocortisone Tablet Hydromorphone HCl Tablet (Extended Release) II (Paddle) 75 Phosphate Buffer, pH 7.5 Refer to USP II (Paddle) 50 Phosphate Buffer pH 6.8 Refer to USP Phosphate Buffer, pH 7.2 Refer to USP 1000 900 10, 15, 20, 30, 45 and 60 04/10/2 008
II (Paddle) 50
900
Hydromorphone HCl Hydroxyurea Hydroxyzine HCl Hydroxyzine Pamoate
Tablet Capsule Tablet Capsule
VII 30 cycles per Water (Reciprocat min ing holder) (Sample holderCage) Refer to USP Refer to USP Refer to USP Refer to USP
50
07/31/2 013 10, 20, 30 02/03/2 and 45 004 10/06/2 008 5, 10, 15 and 02/04/2 30 004 05/09/2 013 1, 2, 4, 6, 8, 05/09/2 10, 12, 16, 20 013 and 24 hours
07/25/2 007 09/03/2 008 07/25/2 007 04/02/2 009
Dissolution Methods
Hydroxyzine Pamoate Suspension Develop a dissolution method Water 50mM Phosphate Buffer, pH 7.2 Refer to USP Phosphate Buffer, pH 7.2 Refer to USP 0.05 M Phosphate Buffer, pH 7.2 Phosphate Buffer, pH 7.2 04/02/2 009 500 900 5, 10, 15, 30 and 45 5, 10, 20, 30 and 45 01/03/2 007 05/09/2 013
Ibandronate Sodium Ibuprofen
Tablet Capsule (SoftGelatin/Liquid Fill) Suspension
Ibuprofen Ibuprofen Ibuprofen Ibuprofen
Suspension/Dro II (Paddle) 50 p Tablet Tablet (Chewable) Capsule (SoftGelatin/Liquid Fill) Capsule II (Paddle) 50
900
900
11/04/2 008 5, 10, 15 and 11/04/2 20 008 07/25/2 007 10, 20, 30 02/04/2 and 45 004 5, 10, 20 and 02/04/2 30 004 10, 20, 30 and 45 10, 20, 30 and 45 10, 15, 20, 30 and 45 01/03/2 007 04/09/2 007 01/05/2 012
Ibuprofen Potassium
I (Basket)
150
900
Ibuprofen/Diphenhydramine
I (Basket)
100
Ibuprofen/Oxycodone HCl
Tablet
I (Basket)
100
Ibuprofen/Phenylephrine HCl Tablet
II (Paddle) 50
Phosphate 900 Buffer (200 mM), pH7.2 Phosphate 500 buffer, pH 7.2 50 mM 900 Potassium
Dissolution Methods
Phosphate Buffer, pH 6.5, (degassed) Tier 1: 0.05 M 900 phosphate buffer, pH 7.2 Tier 2: 0.05 M phosphate buffer, pH 7.2 with NMT 1750 USP protease units/L of 1 X USP pancreatin 0.05 M 900 Phosphate Buffer, pH 7.2 Develop an in vitro release method using USP IV (FlowThrough Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate pharmacopoeial
Ibuprofen/Pseudoephedrine HCl
Capsule
I (Basket)
150
10, 20, 30 and 45
03/04/2 006
Ibuprofen/Pseudoephedrine HCl Icosapent Ethyl
Suspension
II (Paddle) 50
5, 10, 15 and 02/04/2 30 004 08/15/2 013
Capsule
Dissolution Methods
apparatus, for comparative evaluation by the Agency. 0.1 N HCl 0.1 N HCl Refer to USP I (Basket) 100 0.1 N HCl 900 without pepsin and with 0.3% pepsin (addition of pepsin is recommended only when significant slow dissolution is observed) Refer to USP 0.1 M Citrate Buffer, pH 3.8 Refer to USP 900
Iloperidone Imatinib Mesylate Imipramine HCl Imipramine Pamoate
Tablet Tablet Tablet Capsule
500 1000
5, 10, 15, 30, 45 and 60 5, 10, 15, 20 and 30
08/05/2 010 09/22/2 011 01/14/2 008 30, 60, 90, 01/14/2 120, 150 and 008 180
Indapamide Indinavir Sulfate Indomethacin
Tablet Capsule Capsule (Extended Release) II (Paddle) 50
10, 15, 20 and 30
04/15/2 008 02/04/2 004 07/25/2 007
Dissolution Methods
Indomethacin Irbesartan Isocarboxazid Isoniazid Isosorbide Dinitrate/Hydralazine HCl Isosorbide Mononitrate Capsule Tablet Tablet Tablet Tablet I (Basket) 100 II (Paddle) 50 Refer to USP Refer to USP 0.1 N HCl Refer to USP 0.05 N HCl 900 900 12/15/2 009 08/11/2 008 10, 20, 30, 45 02/04/2 and 60 004 04/15/2 008 10, 15, 20, 06/10/2 25, 30 and 009 45 11/25/2 008 5, 10, 15 and 30 15, 30, 45, 60 and 90 02/04/2 004 10/06/2 008
Isosorbide Mononitrate Isotretinoin
Tablet (Extended Release) Tablet Capsule
Refer to USP
II (Paddle) 50 I (Basket, with 20 mesh) 100
Isradipine
Capsule
II (Paddle) 50
Water 900 (deaerated) 0.05 M 900 Potassium Phosphate Buffer, dibasic, pH 7.8, containing 0.5% solid LDAO 0.1% Lauryl 500 Dimethylamine Oxide (LDAO) in water
10, 20, 30, 45 02/25/2 and 60 004
Dissolution Methods
Isradipine (10 mg) Tablet (Extended Release) Tablet (Extended Release) Capsule II (Paddle) 50 0.2% Lauryl 1000 Dimethylamine Oxide (LDAO) in water 0.2% Lauryl 500 Dimethylamine Oxide (LDAO) in water SGF without 900 Enzyme 0.1 N HCl 900 2, 4, 8, 12, 16 02/25/2 and 24 hours 004
Isradipine (5 mg)
II (Paddle) 50
2, 4, 8, 12, 16 02/25/2 and 24 hours 004
Itraconazole
II (Paddle) 100
Itraconazole
Tablet
II (Paddle) 75
Ivermectin
Tablet
II (Paddle) 50
Ketoconazole
Tablet
I (Basket)
100
Ketoprofen
Tablet
II (Paddle) 50
Ketoprofen
Capsule
II (Paddle) 50
0.5% SDS in 0.01 M Monobasic Sodium Phosphate, pH 7.0 Simulated gastric fluid w/o pepsin SIF Buffer without enzyme, pH 7.4 0.05 M
900
10, 20, 30, 45, 60 and 90 5, 15, 30, 45, 60, 75 and 90 10, 20, 30, 45 and 60
02/04/2 004 08/15/2 013 02/04/2 004
800
15, 30, 45, 60 01/03/2 and 90 007 10, 20, 30, 45 02/05/2 and 60 004 10, 20, 30 07/25/2
900
1000
Dissolution Methods
Ketorolac Tromethamine Labetalol HCl Lacosamide Tablet Tablet Tablet II (Paddle) 50 II (Paddle) 50 II (Paddle) 75 II (Paddle) 75 Phosphate Buffer pH 7.4 Refer to USP Refer to USP 0.1 N HCl Water (deaerated) 0.1 N HCl 0.1 N HCl 900 900 900 900 and 45 007 04/15/2 008 08/27/2 009 10, 15, 20, 30 06/07/2 and 45 012 10, 20, 30 03/22/2 and 45 006 5, 10, 15 and 03/22/2 30 006 5, 10, 15, 20, 01/03/2 30 and 40 007
Lamivudine (for 100 mg & 150 Tablet mg) Lamivudine (for 300 mg only) Tablet Lamivudine 150 Tablet mg/Zidovudine 300mg Tablets and Abacavir Sulfate 300 mg Tablets-co-packaged Lamivudine/Stavudine/Nevira Tablet pine Lamivudine/Zidovudine Tablet Lamivudine/Zidovudine + Efavirenz Tablet (Copackage)
II (Paddle) 75 II (Paddle) 75 II (Paddle) Lamivudine and Zidovudine: 75 Efavirenz: 50 II (Paddle) 50
0.1 N HCl 0.1 N HCl Lamivudine and Zidovudine: 0.1 N HCl Efavirenz: 2% SLS in water
900 900
Lamivudine/Zidovudine +
Tablet
Lamivudine and Zidovudine: 1000 Efavirenz: 900 Lamivudine and 900
10, 20, 30, 45 and 60 10, 20, 30 and 45 10, 20, 30, and 45
01/03/2 007 02/20/2 004 01/03/2 007
10, 15, 30, 45 01/03/2
Dissolution Methods
Nevirapine (Copackage) Zidovudine: water Nevirapine: 0.06 M HCl (pH 1.2) 0.01 N HCl 900 0.1 N HCl 0.1 N HCl 900 900 and 60 007
Lamivudine/Zidovudine/ Nevirapine Lamotrigine Lamotrigine
Tablet Tablet (Regular) Tablet (Chewable dispersible) Tablet (Extended Release)
10, 15, 30, 45 and 60 5, 10, 15, 20 and 30 5, 10, 15, 20 and 30
01/03/2 007 03/04/2 006 01/14/2 008
Lamotrigine
II (Paddle)
50
Lansoprazole
Capsule (Delayed
Acid Stage: Acid Stage: 0.01M HCl; 700; Buffer Buffer Stage: Stage: 900 Phosphate Buffer, pH 6.8 + 0.5% SLS (Add 200 mL of 0.0205M tribasic sodium phosphate (pH 12) solution containing 2.25% w/v SLS to 700 mL of HCl) Refer to USP
Acid stage: 03/25/2 120; Buffer 010 stage: 1, 2, 3, 5, 7, 10, 12 and 15 hours
11/04/2 008
Dissolution Methods
Lansoprazole Release) Tablet (Delayed II (Paddle) 75 Release, Orally Disintegrating) Acid Stage: 0.1 500 (Acid), N HCl; Buffer 900 (Buffer) Stage: Phosphate Buffer, pH 6.8 with 5 mM Sodium Dodecyl Sulfate 0.25 N HCl 900 (modified from the standard apparatus 3 vessel to achieve sink condition) 2% Polysorbate 900 80 in 0.1 N HCl Water 1000 (deaerated) Water 1000 (deaerated) + 0.6% Polyoxyethylene Lauryl Ether 0.01 N HCl 900 60 (Acid), 10, 11/04/2 20, 30 and 45 008 (Buffer)
Lanthanum Carbonate
Chewable Tablet
Reciprocati 10 dpm (dip ng Cylinder rate per (Apparatus minute) 3 modified)
10, 20, 30 and 45
01/03/2 007
Lapatinib Ditosylate Leflunomide Leflunomide (100 mg)
10, 15, 30 and 45 10, 20, 30 and 45 10, 20, 30 and 45
10/30/2 009 02/05/2 004 05/31/2 007
Lenalidomide
Capsule
II (Paddle) 50
10, 15, 20, 30 04/15/2 and 45 008
Dissolution Methods
Letrozole Leucovorin Calcium Leuprolide Acetate Tablet Tablet Injectable (Extended Release) Refer to USP Refer to USP Develop a dissolution method using USP IV (FlowThrough Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 0.05 M 900 Phosphate Buffer, pH 6.0 Water 900 (deaerated) Water 900 0.1 N HCl 900 04/10/2 008 07/14/2 008 01/15/2 010
Levetiracetam
Levetiracetam
Tablet (Extended Release) Tablet
I (Basket)
100
1, 2, 4, 6, 8 04/02/2 and 12 hours 009 5, 10, 15 and 30 10, 20, 30 and 45 10, 20, 30 and 45 02/05/2 004 08/11/2 008 06/18/2 007
II (Paddle) 50 II (Paddle) 50 I (Basket) 100
Levocetirizine Dihydrochloride Tablet Levofloxacin Tablet
Dissolution Methods
Levonorgestrel Tablet II (Paddle) 75 0.1 N HCl with 0.1% SLS Refer to USP Paddle 50 over Disk (Apparatus 5) I (Basket) 50 II (Paddle) 50 Acetic acid/sodium acetate buffer, pH 4.0 at 32C 0.1 N HCl 0.05 M Phosphate Buffer, pH 6.8 0.05 M Phosphate Buffer, pH 6.8 Refer to USP 0.1 N HCl Refer to USP Refer to USP 500 10, 20, 30, 60, 120 and 180 5, 10, 15, 20, 30 and 45 5, 10, 20, 30 and 45 10, 20, 30 and 45 1000 10, 20, 30, 45, 60 and 90 02/05/2 004 07/25/2 007 01/03/2 007
Levothyroxine Sodium Lidocaine
Tablet Topical Patch
Linagliptin Linezolid
Tablet Tablet
900 900
08/15/2 013 01/14/2 008 01/14/2 008
Linezolid
Suspension
II (Paddle) 50
900
Liothyronine Sodium
Tablet II (Paddle) 50
Lisdexamfetamine Dimesylate Capsule Lisinopril Lithium Carbonate Tablet Tablet (Extended Release) Tablet
900
06/18/2 007 5, 10, 15 and 10/06/2 20 008 01/14/2 008 01/14/2 008 04/10/2
Lithium Carbonate
Refer to USP
Dissolution Methods
Lithium Carbonate Lomefloxacin HCl Lomustine Capsule Tablet Capsule II (Paddle) 50 Refer to USP 0.01 N HCl Develop a dissolution method Tier 1: 0.05 M Polyoxyethylene 10 Lauryl Ether with 10 mM Sodium Phosphate monobasic (pH 6.8); Tier II: same as above with NMT 1750 USP units/L of Pancreatin 0.06 M Polyoxyethylene 10 Lauryl Ether SGF without enzyme 0.1 N HCl 900 10, 20, 30 and 45 008 07/25/2 007 02/05/2 004
Lopinavir/Ritonavir
II (Paddle) 50
900
10, 15, 30 and 45
06/18/2 007
Lopinavir/Ritonavir
Tablet (Combination) Tablet (Orally Disintegrating) Tablet (Chewable)
II (Paddle) 75
900
15, 30, 60, 90, and 120 2, 4, 6 and 10 15, 30, 45 and 60
09/13/2 007 07/14/2 008 07/14/2 008
Loratadine Loratadine
I (Basket)
50
900 500
II (paddle) 50
Dissolution Methods
Loratadine Capsule (SoftGelatin) II 75 (Paddle) wi th sinker Tier I: 0.1N HCl 900 with 0.1% Tween 20. Tier II: 0.1N HCl with 0.1% Tween 20 with addition of pepsin (as per USP). 900 mL 0.1 N 900 HCl for one hour, then replace the medium with 900 mL 0.05 M phosphate buffer at pH6.8 containing 0.01% sodium lauryl sulfate. 900 mL 0.1 N 900 HCl for one hour, then replace with 900 mL 0.05 M phosphate buffer at pH 8.2 containing 0.01% sodium 10, 20, 30, 45 02/28/2 and 60 013
Loratadine/Pseudoephedrine Tablet Sulfate (10 mg /240 mg) (Extended Release)
I (Basket)
75
Loratadine:10 08/05/2 , 15, 20, 30 010 and 45; Pseudoephed rine: 1, 2, 4, 8, 12, 16, 18 and 24 hours
Loratadine/Pseudoephedrine Tablet Sulfate (5 mg /120 mg) (Extended Release)
II (Paddle) 50
Loratadine:15 08/05/2 , 20, 30, 45, 010 60 and 90; Pseudoephed rine: 1, 2, 4, 8, 12 and 16 hours
Dissolution Methods
Lorazepam Losartan Potassium Losartan Potassium Loteprednol Etabonate/Tobramycin Tablet Tablet Tablet Ophthalmic Suspension II (Paddle) 50 lauryl sulfate Refer to USP Refer to USP Water (deaerated) Develop a method to characterize in vitro release For Niacin: Water; for Lovastatin: 0.05 M phosphate buffer, pH 7.0 with 0.5% sodium dodecyl sulfate 0.1 N HCl/1% HCO-40 (Polyoxyl 40 hydrogenated castor oil) McIlvaine buffer, pH 3.8 [(0.0.025 M Citric acid 900 10, 20, 30 and 45 01/14/2 008 01/05/2 012 02/06/2 004 01/31/2 013
Lovastatin/Niacin
I (Basket)
100
900
For Niacin: 01/14/2 0.5, 1, 2, 3, 6, 008 9, 12, 20 and 24 hours; For Lovastatin: 15, 30, 45 and 60 min 15, 30, 45, 60, 90 and 120 08/19/2 010
Lubiprostone
II (Paddle)
50
900
Lurasidone HCl
Tablet
II (Paddle) 50
900
5, 10, 15, 20 and 30
01/31/2 013
Dissolution Methods
Solution + 0.05M Na2HPO4 solution (3:2)] Measure the pH and adjust to 3.8, if necessary. Degas before use. pH 7.4 900 Phosphate Buffer with 0.5% SDS 0.029 M sodium 900 phosphate buffer w/ 0.5% SDS, pH 7.4 0.01 N HCl 900 0.1 N HCl containing 1% Sodium Lauryl Sulfate 0.01 N HCl 0.01 N HCl 900
Magnesium Tablet Hydroxide/Omeprazole/Sodiu (Chewable) m Bicarbonate Magnesium Tablet Hydroxide/Omeprazole/Sodiu (Chewable) m Bicarbonate Maraviroc Mebendazole Tablet Tablet (Chewable)
II (Paddle) 150
15, 30, 45, 60 10/06/2 and 90 008
II (Paddle) 150
15, 30, 45, and 60
02/19/2 008
I (Basket)
100
II (Paddle) 75
10, 15, 20, 30 and 45 15, 30, 45, 60, 90 and 120 10, 20, 30, 45 and 60 10, 20, 30, 45 and 60
10/21/2 010 10/06/2 008
Meclizine HCl Meclizine HCl
Tablet (Chewable) Tablet
I (Basket) I (Basket)
100 100
900 900
04/08/2 010 08/27/2 009
Dissolution Methods
Medroxyprogesterone Acetate Injectable Suspension Test 1: IV Test 1: 17 (Flow mL/min; Test through 2: 50 rpm cell), 22.6 mm cell, 13 g of 1 mm beads; Test 2: II (Paddle) Test 1: 0.5 % SDS in water ; Test 2: 0.35 % SDS in water (provide data with both tests) Test 1:use Open Mode: Test 2: 900 mL Test 1: 5, 10, 10/31/2 15, 20, 30, 013 40, 50, 60, 70, 80 and 90; Test 2: 5, 10, 15, 30, 60, 90, 120, 240, 360, 1440 and 2880 12/15/2 009 10, 20, 30, 45 02/06/2 and 60 004 12/15/2 009 5, 10, 15 and 01/26/2 30 006 10, 20, 30, 45 02/20/2 and 60 004 07/14/2 008 1, 2, 4, 6, 8, 10/28/2 10, 12 and 16 010 hours 10, 20, 30 12/16/2
Mefenamic Acid Mefloquine HCl Megestrol Acetate Meloxicam Meloxicam Melphalan Memantine HCl
Capsule Tablet Oral Suspension Suspension Tablet Tablet Capsule (Extended Release) Tablet I (Basket) 100 I (Basket) 100
Refer to USP SGF without enzyme Refer to USP 900
Phosphate 900 buffer at pH 7.5 Phosphate 900 Buffer, pH 7.5 Refer to USP pH 1.2 Buffer, 900 Simulated Gastric Fluid without enzyme 0.1 N HCl with 900
Memantine HCl
I (Basket)
100
Dissolution Methods
NaCl (12 g NaCl in 6 L water adjust pH to 1.2 with HCl) Neutralized 900 phthalate buffered solution (0.2 M potassium biphthalate) with pH of 5.0 at 32 0.5C Refer to USP 0.1 N HCl 900 and 45 005
Menthol/Methyl Salicylate
Topical Patch
VI (Cylinder)
50
10, 20, 30, 60, 120, 150 and 180
01/31/2 013
Meprobamate Mercaptopurine
Tablet Tablet II (Paddle) 50
Mesalamine
Suppository
II (Paddle) 75 (for 500 with option mg) & 125 to use a (for 1000 mg) sinker
Mesalamine (1.2 gram)
Tablet (Delayed II (Paddle) 100
For 500 mg 900 strength: 0.2 M Phosphate buffer, pH 7.5 at 37 deg. C For 1000 mg strength: 0.2 M Phosphate buffer, pH 7.5 at 40 deg. C Acid stage (A): Acid stage
20, 30, 45, 60, 90 and 120 30, 60, 90, 120 and 150
11/25/2 008 02/06/2 004 01/30/2 006
Acid stage
06/10/2
Dissolution Methods
Release) 100 mM HCl Buffer stage (B): Phosphate Buffer, pH 6.4 Buffer stage (C): Phosphate Buffer, pH 7.2 Refer to USP (A): 750 mL; Buffer stage (B): 950 mL; Buffer stage (C): 960 mL (A): 2 hours; 009 Buffer stage (B): 1 hour; Buffer stage (C): 1, 2, 4, 6 and 8 hours 06/10/2 009 Acid stage: 2 06/10/2 hours; Buffer 009 stage: 0.5, 1, 2, 4, 7 and 9 hours 11/05/2 010 5, 10, 15, and 06/18/2 30 007 5, 10, 15, 20 02/09/2 and 30 004 03/25/2 010 30, 60, 90 02/06/2 and 120 004 12/12/2 008
Mesalamine (250 mg and 500 Capsule mg) (Extended Release) Mesalamine (375 mg) Capsule (Extended Release)
I (Basket)
100
Mesalamine (400 mg and 800 Tablet (Delayed mg) Release) Mesalamine Enema Rectal Enema II (Paddle) 50 Mesna Mestranol/Norethindrone Metaxalone Metformin HCl Tablet Tablet Tablet Tablet (Extended II (Paddle) 100 II (Paddle) 50
Acid Stage: 0.1N Acid stage: HCl Buffer 750 mL; stage: Buffer stage: Phosphate 1000 mL Buffer, pH 6.8 Refer to USP Phosphate Buffer, pH 7.2 0.06 N HCl Refer to USP 0.5% SLS in water Refer to USP 900 900 500
Dissolution Methods
Metformin HCl Metformin HCl/Pioglitazone HCl Release) Tablet Tablet II (Paddle) 50 Refer to USP pH 2.5 McIlvaine 900 buffer (0.1 M Citric acid adjusted to pH 2.5 with 0.2 M Na2HPO4) Phosphate 1000 Buffer, pH 6.8 10, 20, 30 and 45 04/10/2 008 01/03/2 007
Metformin HCl/Saxagliptin
I (Basket)
100
Metformin HCl/Sitagliptin Phosphate Metformin/Repaglinide
Tablet Tablet
0.025 M NaCl Citric acid/phosphate buffer, pH 5.0 Refer to USP Refer to USP Refer to USP
900 900
Metformin: 1, 2, 3, 4, 6, 8, 10 and 12 hours. Saxagliptin: 5, 10, 15, 20 and 30 minutes 10, 15, 20 and 30 5, 10, 15, 20 and 30
01/26/2 012
10/06/2 008 10/30/2 009 07/14/2 008 07/31/2 013 01/14/2
Methadone HCl Methenamine Hippurate Methimazole
Dissolution Methods
Methocarbamol Methotrexate Sodium Methoxsalen Methylphenidate Tablet Tablet Capsule Capsule (Extended Release) II (Paddle) 50 Refer to USP Refer to USP Refer to USP Water 500 008 08/15/2 013 04/02/2 009 03/25/2 010 1, 2, 4, 6, 8, 04/15/2 12 hours and 008 until at least 80% released 1, 2, 4, 6, 8 04/15/2 and 10 hours 008
Methylphenidate
Methylphenidate
Transdermal Patch
VII 30 cycles per Water, pH 3.0 (Reciprocat min ing holder) with oral extended release tablet holder (spring holder) VI 50 0.01 N HCl at (Cylinder) 32C
250
900
0.5, 1.5, 3, 4 hours and until at least 80% released
04/15/2 008
Dissolution Methods
Methylphenidate (BX) Capsule (Extended Release) Tablet Tablet (Chewable) Tablet Injectable Suspension I (Basket) 100 I (Basket) 75 0-2 hrs:0.01 N HCl. 2-10 hrs: Phosphate Buffer, pH 6.8. Refer to USP Water Refer to USP IV (FlowThrough Cell-Open system) 0.55 % SDS 15, 30, 45, 60, 90 and 120 0-2 hrs: 500. 2-10 hrs:500 0.5, 1, 3, 6, 8 07/25/2 and 10 hours 007
Methylphenidate HCl Methylphenidate HCl Methylprednisolone Methylprednisolone Acetate
900
15, 30, 45 and 60
07/14/2 008 03/25/2 010 01/29/2 010 10/08/2 009
Methyltestosterone Methyltestosterone
Capsule Tablet II (Paddle) 50
Refer to USP Water 900 10, 20, 30, 45, 60 and 75
07/31/2 013 07/31/2 013
Metoclopramide HCl Metoclopramide HCl Metolazone
Tablet Tablet (Orally Disintegrating) Tablet I (Basket) 50
Refer to USP Water 900
II (Paddle) 75
2% SLS in 0.05 900 M Sodium Phosphate Buffer, pH 7.5
07/15/2 009 5, 10, 15, 20, 04/08/2 30 and 45 010 30, 60, 90, 02/10/2 120 and 150 004
Dissolution Methods
Metoprolol Succinate Tablet (Extended Release) Tablet Capsule Tablet Tablet (Buccal) I (Basket) 60 I (Basket) 100 Refer to USP 07/25/2 007 07/25/2 007 02/09/2 004 08/05/2 010 10/28/2 010
Metoprolol Tartrate Metronidazole Metronidazole Miconazole
Refer to USP 0.1 N HCl Refer to USP 0.5% SDS 1000 (Sodium dodecylsulfate) in water-pH adjusted to 6.5 0.5 0.45% SLS in 900 water 0.1 N HCl 900 0.01 N HCl Water 0.1 N HCl 0.1 N HCl 900 900 1000 900 1, 2, 4, 6, 8, 10 and 12 hours 900 10, 20, 30 and 45
Miconazole Nitrate Midodrine HCl Mifepristone Miglitol Miglustat Milnacipran HCl
Suppository (Vaginal) Tablet Tablet Tablet Capsule Tablet
I (Basket)
100
II (Paddle) 50 II (Paddle) 75 II (Paddle) 75 I (Basket) 100
II (Paddle) 50
15, 30, 45 and 60 5, 10, 15 and 30 5, 10, 15, 20 and 30 10, 20, 30, and 45 10, 20, 30 and 45 10, 15, 30, 45 and 60
10/08/2 009 02/06/2 004 01/14/2 008 03/03/2 011 01/03/2 007 08/05/2 010
Dissolution Methods
Minocycline HCl ER Tablets I (Basket) 100 0.1 N HCl 900 1, 2, 4, 6 hours and until 80% of drug released 01/14/2 008
Minocycline HCl Minocycline HCl Minoxidil Mirabegron
Capsule Tablet Tablet Tablet (Extended Release) Tablet Tablet (Orally Disintegrating (ODT)) Tablet Tablet Tablet Tablet II (Paddle) 50 II (Paddle) 50 I (Basket) 100
Refer to USP Refer to USP Refer to USP Phosphate Buffer, pH 6.8 0.1 N HCl 0.1 N HCl 900
Mirtazapine Mirtazapine
900 900
04/15/2 008 07/25/2 007 04/15/2 008 1, 3, 5, 7, 8.5, 05/09/2 10 and 12 013 hours 5, 10, 15 and 02/10/2 30 004 5, 10, 15, 20 03/04/2 and 30 006 5, 10, 20 and 02/10/2 30 004 06/10/2 009 10, 20, 30, 45 02/10/2 and 60 004 5, 10, 15 and 02/10/2 30 004
Misoprostol Mitotane Modafinil Moexipril HCl
II (Paddle) 50
Water (deaerated) Refer to USP 0.1 N HCl Water (deaerated)
500
900 900
Dissolution Methods
Molindone HCl Montelukast Tablet Granule I (Basket) 50 (100 mesh) II (Paddle) 50 II (Paddle) 50 Refer to USP 0.5% w/v SDS in 900 Water 0.5% SDS in water 0.5% SDS in water Refer to USP 900 900 07/25/2 007 5, 15, 20 and 09/24/2 30 008 5, 10, 20 and 30 5, 10, 20 and 30 04/09/2 007 03/04/2 006 08/11/2 008 01/15/2 010 12/23/2 010 12/23/2 010 01/26/2 012
Montelukast Sodium Montelukast Sodium Morphine Sulfate
Tablet Tablet (Chewable) Capsule (Extended Release) Tablet Tablet (Extended Release) Tablet (Extended Release) Capsule (Extended Release)
Morphine Sulfate Morphine Sulfate (AB)
Deionized Water Water (deaerated) Water
900 900
5, 15, 20 and 30 1, 2, 3, 6, 9 and 12 hours 1, 2, 4, 6, 8, 10 and 12 hours Morphine Sulfate: Acid stage: 1 hour; Buffer stage: 1, 3, 5, 8 and 10 hours. Naltrexone
Morphine Sulfate (BC)
I (Basket)
100
500
Morphine Sulfate/Naltrexone HCl
II (Paddle) 50
Acid stage: 0.1 N HCl; Buffer stage: 0.05 Phosphate Buffer, pH 7.5
Dissolution Methods
HCl: Acid stage: 1 hour; Buffer stage: 1, 12, 24, 48, 73 and 96 hours. 0.1 N HCl 900 15, 30, 45 and 60 0.1 N HCl 900 5, 10, 20 and 30 0.1 N HCl 900 5, 10, 20 and 30 0.1 N HCl 900 5, 10, 15 and 30 Acid Stage: 0.1 750 (Acid), 120 (Acid), N HCl; Buffer 1000 (Buffer) 10, 20, 30, 45 Stage: Buffer and 60 Solution, pH 6.8 (Buffer) (After initial 120 mins., 250 mL of 0.2 M sodium phosphate solution is added to acid stage medium. The pH of the mixture is adjusted to 6.8 using 0.2 M
Moxifloxacin Mycophenolate Mofetil Mycophenolate Mofetil Mycophenolate Mofetil Mycophenolic acid
Tablet Suspension Capsule Tablet
II (Paddle) 50 II (Paddle) 40 II (Paddle) 40 II (Paddle) 50
Tablet (Delayed II (Paddle) 50 Release)
06/18/2 007 02/10/2 004 02/10/2 004 02/10/2 004 12/19/2 008
Dissolution Methods
sodium phosphate, 2 N sodium hydroxide, or concentrated HCl acid solution if necessary.) 0.1% Tween 80 1000 solution Refer to USP Refer to USP Phosphate buffered saline with 0.02% Tween 20 and 0.02% Sodium azide, pH 7.4 (final osmolality should be 270 20 mOsm), or any other appropriate medium, at 37C. Develop an in vitro release method
Nabilone Nabumetone Nadolol Naltrexone
Capsule Tablet Tablet Injectable Suspension
II (Paddle) 50
15, 30, 45 and 60
07/14/2 008 07/25/2 007 04/02/2 009 09/01/2 011
Dissolution Methods
using USP IV (Flow-Through Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency Refer to USP Refer to USP Refer to USP Refer to USP II (Paddle) 50 Phosphate Buffer, pH 7.5 Phosphate Buffer, pH 6.8 900
Naltrexone HCl Naproxen Naproxen Naproxen Sodium Naproxen Sodium
Tablet Tablet (Delayed Release) Tablet Tablet Tablet (Extended Release) Tablet
Naproxen Sodium/Sumatriptan Succinate Naproxen/Esomeprazole
I (Basket)
75
900
04/15/2 008 12/15/2 009 07/25/2 007 10/04/2 012 0.5, 1, 2, 3, 4, 04/08/2 6, 8, 10, 12 010 and 14 hours 10, 15, 20, 30 07/01/2 and 45 010 06/06/2
Tablet (Delayed II (Paddle) Naproxen::50 Naproxen:: Acid Naproxen::Aci Naproxen::
Dissolution Methods
Magnesium Release) with sinkers rpm Stage: 0.1M Esomeprazol HCl; Buffer e::75 rpm Stage: 0.05M Phosphate buffer, pH 6.8. Sampling for Acid stage: Transfer the undissolved tablet & sinker to the vessel containing the buffer stage medium. Add, 10 mL of 10 M NaOH to each vessel of the remaining acid stage medium. Continue rotation at 100 rpm for 30 minutes, withdraw aliquot and analyze. Esomeprazole (second set of tablets)(without pre-exposure to d Stage: 1000; Buffer Stage: 1000; Esomeprazol e::900 Acid stage: 013 120; Buffer stage: 10, 20, 30, 45, 60, 75 and 90; Esomeprazol e::10, 20, 30, 45, 60, 75 and 90
Dissolution Methods
acid stage):: 0.05M Phosphate buffer, pH 7.4 Refer to USP II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 0.01 N HCl with 1000 0.5% (w/v) SLS 0.01 N HCl 900 0.1 N HCl 0.1 N HCl 900 900
Naratriptan HCl Nateglinide Nebivolol HCl Nefazodone HCl Nelfinavir Mesylate
Tablet Tablet Tablet Tablet Tablet
Nelfinavir Mesylate Neomycin Sulfate
Powder for suspension Tablet
0.1 N HCl
900
Nevirapine
I (Basket)
75
Nevirapine
Suspension
II (Paddle) 25
0.05 M 900 Phosphate Buffer, pH 6.8 0.04 M Sodium 900 phosphate buffer pH 6.8 containing 2% sodium lauryl sulfate 0.1 N HCl 900
07/25/2 007 10, 20, 30 01/03/2 and 45 007 10, 20, 30 01/15/2 and 45 010 10, 20, 30, 45 01/03/2 and 60 007 5, 10, 15, 20, 01/03/2 30, 45, 60 007 and 90 5, 10, 15, 20, 09/13/2 30, and 45 007 15, 30, 45 01/14/2 and 60 008 1, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 20 hours 01/31/2 013
10, 20, 30, 45 02/11/2
Dissolution Methods
and 60 Nevirapine Niacin Tablet Tablet (Extended Release) Tablet (Extended Release) I (Basket) 100 Refer to USP Water 900 004 09/13/2 007 1, 3, 6, 9, 12, 06/10/2 15, 20 and 24 009 hours Niacin: 1, 3, 01/15/2 6, 9, 12, 15, 010 18, 20 and 24 hours; Simvastatin: 10, 20, 30, 45 and 60
Niacin/Simvastatin
Nicardipine HCl
Nicardipine HCl
Capsule (Extended Release) Capsule
Niacin: I 100 (40 mesh rotating Basket); Simvastain : I (10 mesh rotating Basket) II (Paddle) 50
Niacin: Water; 900 Simvastatin: 0.5 % SDS in 0.01 M Sodium Phosphate, pH 7.0
0.1 N HCl
1000
0.5 , 2 and 6 hours 10, 20, 30 and 45
07/14/2 008 02/11/2 004 01/31/2 013
II (Paddle) 50
Nicotine
Nicotine Polacrilex
Film, Transdermal (Extended Release) Chewing Gum
0.033 M Citric Acid Buffer, pH 4.5 Refer to USP
900
Chewing 60 cycles Machine as (chews) per
Phosphate 20 Buffer, pH 7.4 or
5, 10, 20 and 01/05/2 30 012
Dissolution Methods
desribed in minute European Pharmacop oeia (2.9.25) I (Basket) 100 I (Basket) 100 or any other appropriate buffer and conditions Phosphate Buffer, pH 7.4 Phosphate Buffer, pH 7.4 Refer to USP Refer to USP 900 900 0.5, 1, 2, 3, 6 and 8 hours 30, 60, 90, 120 and 180 12/23/2 010 12/23/2 010 03/03/2 011 07/25/2 007 10/30/2 009 05/20/2 009 04/09/2 007 04/02/2 009
Nicotine Polacrilex Nicotine Polacrilex Nifedipine Nifedipine
Lozenge Lozenge (Mini) Capsule Tablet (Extended Release) Capsule Tablet
Nilotinib Hydrochloride Monohydrate Nilutamide
I (Basket)
100
0.1 N HCl
1000
10, 15, 30 and 45
Nimodipine Nisoldipine
Capsule Tablet (Extended Release)
II (Paddle) 50 II (Paddle) 50 with option to use a sinker
Develop a dissolution method 0.5% SDS in 900 water HCl with SLS 900 (32.5 0.1 g Sodium Lauryl Sulfate in 6489 mL of purified water containing
10, 20, 30, and 45 1, 4, 8, 12, 15, 18 and 24 hours
Dissolution Methods
17.0 mL HCl, pH adjusted to 1.20 0.05 with HCl) Phosphate 900 buffer at pH 7.5 with 6% hexadecyltrimet hyl ammonium bromide, bath temperature at 25C Phosphate 900 buffer at pH 7.5 with 6% hexadecyltrimet hyl ammonium bromide, bath temperature at 25C Refer to USP Phosphate 900 Buffer, pH 7.2 Phosphate 500 Buffer, pH 6.5 Deionized Water 900 at 32 C
Nitazoxanide
Oral Suspension
II (Paddle
100
10, 20, 30, 45 10/21/2 and 60 010
Nitazoxanide
Tablet
II (Paddle) 75
10, 20, 30, 45, 60
01/03/2 007
Nitrofurantoin Nitrofurantoin Nitroglycerin Nitroglycerin
Capsule Suspension Tablet (Sublingual) Film, Transdermal (Ex tended II (Paddle) 50 II (Paddle) 50 Modified 100 USP Type V (Paddle-
04/02/2 009 15, 30, 60, 04/02/2 120 and 180 009 1, 3, 5, 8, and 01/15/2 10 010 10, 20, 30, 04/08/2 45, 60, 90, 010 120 and 180
Dissolution Methods
Nizatidine Norethindrone Norethindrone Acetate Nystatin Nystatin Octreotide Injection Release) Capsule Tablet Tablet Tablet Oral Suspension Injectable (Extended Release) II (Paddle) 75 II (Paddle) 25, 50 and 75 over-disk) Refer to USP Refer to USP Refer to USP Water with 0.1% 900 SLS 0.1 % and 0.2% 900 SLS in water Develop a dissolution method using USP IV (FlowThrough Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 0.1 N HCl 900 01/14/2 008 10/08/2 009 08/27/2 009 15, 30, 45, 60 01/03/2 and 90 007 5, 10, 20, 30, 10/28/2 45 and 60 010 12/23/2 010
Ofloxacin
Tablet
I (Basket)
100
10, 20, 30
02/12/2
Dissolution Methods
Olanzapine Olanzapine (Orally disintegrating) Olmesartan Tablet Tablet (Orally Disintegrating) Tablet II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 0.1 N HCl 0.1 N HCl 0.05 M Phosphate Buffer, pH 6.8 Phosphate Buffer, pH 7.5 Refer to USP 900 900 900 and 45 5, 10, 20 and 30 5, 10, 15 and 30 10, 20, 30 and 45 10, 20, 30 and 45 004 02/12/2 004 02/12/2 004 07/09/2 007 02/12/2 004 06/18/2 007
Olsalazine Sodium Omeprazole
Capsule Capsule (Delayed Release) OTC Tablet (Delayed Release)
I (Basket)
100
900
Omeprazole
II (Paddle)
100
Omeprazole Magnesium
OTC Tablet (Delayed Release)
II (Paddle) 100
Tablets are preexposed to 750 ml of 0.1M HCL for 2 hrs and then 250 ml of 0.2M Na3PO4 is added to the medium to give 1000 ml with pH 6.8 Tablets are preexposed to 300 ml of 0.1M HCL for 2 hrs and
Acid stage: 02/28/2 120; Buffer 013 stage: 10, 20, 30, 45 and 60
300 ml for the acid stage; 1000 ml for the buffer
Sampling 01/03/2 started at the 007 buffer stage 10, 20, 30, 45
Dissolution Methods
then 700 ml of stage 0.086 M Na2HPO4 is added to the medium containing the capsule to give 1000 ml with pH 6.8 0.25 mM 900 Sodium Phosphate Buffer, pH 7.4 Phosphate 900 Buffer, pH 7.4 Refer to USP 0.1 N HCl 900 and 60
Omeprazole Sodium Bicarbonate
Omeprazole Sodium Bicarbonate Ondansetron Ondansetron
Powder for suspension (Immediate Release) Capsule Tablet (Orally Disintegrating) Film (Oral)
II (Paddle) 50
5, 10, 15, and 06/20/2 30 007
II (Paddle) 75
15, 30, 45 and 60
Ondansetron HCl Orlistat
Tablet Capsule
V (Paddle 50 over Disk) with a stainless steel disk (120 mesh screens) II (Paddle) 50 II (Paddle) 75
5, 10, 15, 20 and 30
07/14/2 008 06/18/2 007 01/26/2 012
Water 500 (deaerated) 3% SLS in 0.5% 900
5, 10, 15 and 02/12/2 30 004 10, 20, 30, 45 02/12/2
Dissolution Methods
Orphenadrine Citrate Tablet (Extended Release) Capsule Sodium Chloride, pH 6.0 Refer to USP and 60 004 08/27/2 009 900 900 1000 5, 10, 20, and 30 5, 10, 15, 20 and 30 10, 20, 30, 45 and 60 10, 20, 30 and 45 1, 2, 4, 6, 8 and 10 hours 10, 20, 30, 45, 60 and 90 10, 20, 30, 45, 60 and 90 10, 20, 30, 45, 60 and 90 1, 4, 24 01/03/2 007 07/15/2 009 02/12/2 004 02/12/2 004 08/15/2 013 02/12/2 004 02/12/2 004 02/12/2 004 01/03/2
Oseltamivir Phosphate Oseltamivir Phosphate Oxaprozin
II (Paddle) 50
0.1 N HCl 0.1N HCl 0.05 M Phosphate Buffer, pH 7.4 1% SDS in water 1.0% SDS in Deionized Water (degassed) 0.3% SDS in water 0.6% SDS in water 1% SDS in water Phosphate
Oral Supension II 25 (Paddle) Tablet II (Paddle) 75
Oxcarbazepine Oxcarbazepine
Suspension Tablet (Extended Release) Tablet
II (Paddle) 75 II (Paddle) 75 with sinker II (Paddle) 60
900 900
Oxcarbazepine (150 mg)
900
Tablet
II (Paddle) 60
900
Tablet
II (Paddle) 60
900
Oxybutynin
Trans-dermal
Paddle
50
900
Dissolution Methods
over Disk (Apparatus 5) Oxybutynin Chloride Tablet (Extended Release) Tablet (Extended Release) Tablet Tablets Tablet (Extended Release) Tablet (Extended Release) Injectable Suspension II (Paddle) 50 II (Paddle) 50 Buffer, pH 4.5 @ 32oC Refer to USP hours 007
Oxycodone HCl
Refer to USP
07/01/2 010 01/14/2 008 10, 20, 30 01/14/2 and 45 008 1, 4, 6, 10, 12/03/2 and 14 hours 007 1, 2, 4, 6, 8, 08/27/2 12, 14, 18 009 and 24 hours 1.5, 5, 8, 10, 15, 20, 30 and 45 09/01/2 011
Oxycodone HCl Oxymorphone HCl Oxymorphone HCl
Refer to USP 0.1 N HCl pH 4.5 phosphate buffer Modified SGF, pH 1.0 [NaCl (0.2% w/w) in 0.0825N HCl] 0.001 M HCl containing 0.489% Polysorbate 20 at 25.0 0.5 C. 0.1 N HCl 900 900
Paliperidone
II (Paddle) 50
500
Paliperidone Palmitate
II (paddle) 50
900
Palonosetron HCl
Capsule
II (Paddle) 75
500
10, 15, 30, 45 08/05/2 and 60 010
Dissolution Methods
Pantoprazole Sodium Delayed Release Granules for Oral Suspension II (Paddle) 100 Acid Stage: 0.1 Acid stage: N Hydrochloric 750; Buffer Acid; Buffer stage: 1000 Stage: 0.05 M Tribasic Sodium Phosphate (Add 250 mL of 0.2 mM Tribasic Sodium Phosphate after completion of acid stage); pH 6.8 (Method B) Refer to USP 4 mg/mL (0.4%) 500 Lauryldimethyla mine N-oxide (LDAO) 0.05 M 900 Phosphate Buffer, pH 6.8 Step 1: 0.1 N 750 (step 1); HCl for 2 hours; 1000 (step 2) Step 2: Tris Buffer containing 50 mM Tris, pH 7.5 Acid stage: 10/30/2 60, 90 and 009 120; Buffer stage: 10, 20, 30, 45 and 60
Pantoprazole Sodium Paricalcitol
Tablet (Delayed Release) Capsule I (Basket)
100
20, 30, 45, 60
07/21/2 009 06/18/2 007
Paromomycin Sulfate
Capsule
I (Basket)
50
5, 10, 15, 20, 02/13/2 30 and 45 004 2 hours (step 11/25/2 1), 1, 2, 4 and 008 6 hours (step 2)
Paroxetine
II (Paddle) 150
Dissolution Methods
Paroxetine HCl Paroxetine HCl Pazopanib HCl Suspension Tablet Tablet II (Paddle) 75 II (Paddle) 100 SGF without enzyme Refer to USP 50 mM Sodium Acetate buffer, pH 4.5, containing 0.75% SDS Water (deaerated) Refer to USP Refer to USP Refer to USP Refer to USP I (Basket) 50 Water Refer to USP 900 5, 15, 30, 45 and 60 900 10, 20, 30 and 45 02/13/2 004 01/14/2 008 10, 15, 30, 45 08/05/2 and 60 010
900
Pemoline
Tablet
II (Paddle) 75
900
10, 20, 30, 45, 60 and 90
02/13/2 004 06/24/2 010 09/03/2 008 06/09/2 011 06/09/2 011 04/15/2 008 06/09/2 011 03/04/2 006
Penbutolol Sulfate Penicillamine Penicillin V Penicillin V Potassium
Tablet Capsule Tablet Tablet
Pentosan Polysulfate Sodium Capsule Pentoxifylline Tablet (Extended Release) Tablet
Pergolide Mesylate
II (Paddle) 50
Simulated gastric fluid TS
500
10, 20, 30 and 45
Dissolution Methods
with cysteine without enzymes 0.1 N HCl Refer to USP Refer to USP Refer to USP II (Paddle) 50 1 hour - SGF w/o Enzymes; after 1 hour SIF w/o Enzymes Simulated Gastric Fluid without enzymes, pH 1.2 Refer to USP Refer to USP Refer to USP 900
Perindopril Erbumine Perphenazine Phendimetrazine Tartrate Phendimetrazine Tartrate Phendimetrazine Tartrate
Tablet Tablet Tablet Capsule Capsule (Extended Release)
II (Paddle) 50
900
10, 20 , 30 and 45
06/20/2 007 12/15/2 009 05/20/2 009 06/10/2 009 1, 2, 4, 6 and 06/10/2 8 hours 009
Phenelzine Sulfate
Tablet
II (Paddle)
50
900
10, 20, 30 and 45
03/25/2 010
Phenoxybenzamine HCl Phentermine HCl Phentermine HCl
Capsule Capsule Tablet
04/10/2 008 01/14/2 008 07/15/2 009
Dissolution Methods
Phentermine HCl Tablet (Orally Disintegrating) II (Paddle) 50 Water 500 mL (15 mg) or 900 mL (30 mg and 37.5 mg) 900 750 5, 10, 15, 20 and 30 07/31/2 013
Phentermine HCl
Tablet
Water Water (deionized and degassed)
Phentermine HCl/Topiramate Capsule (Extended Release)
10, 20, 30, 45 and 60 Phentermine: 10, 15, 20, 30 and 45; Topiramate: 0.5, 1, 2, 3, 4, 6 and 8 hours
08/27/2 009 06/06/2 013
Phenytoin Phenytoin Phenytoin Sodium Phytonadione
Tablet (Chewable) Suspension Capsule Tablet
Refer to USP Refer to USP Refer to USP Develop a dissolution method 0.1 N HCl Refer to USP
01/14/2 008 06/18/2 007 06/18/2 007 03/25/2 010 500 10, 20, 30, 45 01/20/2 and 60 004 02/19/2 008
Pilocarpine HCl Pimozide
Tablet Tablet
II (Paddle) 50
Dissolution Methods
Pioglitazone HCl Piroxicam Pitavastatin Calcium Tablet Capsule Tablet I (Basket) 35 II (Paddle) 75 HCl-0.3 M KCl Buffer, pH 2.0 Refer to USP 0.05 M Phosphate Buffer, pH 6.8 0.3% SLS Refer to USP 900 5, 10, 15 and 02/13/2 30 004 10/04/2 012 5, 10, 15, 20, 12/23/2 30 and 45 010 10, 20, 30 and 45 12/03/2 007 07/25/2 007
900
Posaconazole Potassium Chloride
Potassium Chloride
Potassium Citrate Pramipexole Dihydrochloride
Oral Suspension Tablet (Extended Release) Capsule (Extended Release) Tablet Tablet (Extended Release) Tablet
II (Paddle) 25
900
Refer to USP
Refer to USP I (Basket) 100 0.05 M 500 phosphate buffer, pH 6.8 0.023 M 500 Citrate/0.155 M Phosphate Buffer, pH 6.8 Citrate900 Phosphate buffer (0.023M
Pramipexole Dihydrochloride
II (Paddle) 50
1, 2, 4, 6, 9, 12, 16, 20 and 24 hours 5, 10, 15, 30 10/09/2 and 45 007
08/05/2 010 09/02/2 010
Prasugrel HCl
Tablet
II (Paddle) 75
10, 15, 20, 30 10/04/2 and 45 012
Dissolution Methods
Citric acid+0.026M Sodium Phosphate, Dibasic), pH 4.0 Water (deaerated) Refer to USP 22 mM Sodium Acetate Buffer, pH 4.5 Water
Pravastatin Sodium Prednisolone Prednisolone Sodium Phosphate Prednisone
Tablet Tablet Tablet (Orally Disintegrating)
II (Paddle) 50
900
II (Paddle) 50
500
5, 10, 20 and 02/13/2 30 004 11/25/2 008 5, 15, 30, 45 09/03/2 and 60 008 1, 2, 3, 3.5, 4, 4.5, 5, 5.5, 6, 7, 8 and 10 hours 10, 20, 30 and 45 07/31/2 013
Tablet (Delayed II (Paddle) 100 Release) with sinker Capsule Tablet Capsules Rectal Suppository II (Paddle) 50 I 100 (Suppositor y, dissolution II (paddle) 50
500
Pregabalin Primidone Procarbazine HCl Prochlorperazine
0.06 N HCl Refer to USP Water
900
900
0.1 N HCl at 38 900 deg. C
03/22/2 006 01/14/2 008 10, 20, 30, 45 01/14/2 and 60 008 10, 20, 30 08/17/2 and 45 006
Dissolution Methods
baskets, palmieri type) Progesterone Capsule Develop a quantitative rupture test 0.25% sodium dodecyl sulfate (SDS) in DI water Refer to USP 0.1 N HCl 0-2 hours: 0.08 N HCl 2-15 hours: phosphate buffer, pH 6.8 Refer to USP Refer to USP 04/08/2 010 900 5, 10, 15, 20 and 30 10/04/2 012
Progesterone
Vaginal Insert
II (Paddle) 50
Promethazine HCl Propafenone HCl Propafenone HCl
Tablet Tablet Capsule (Extended Release) II (Paddle) 75 II (Paddle) 50
900 900
07/25/2 007 10, 20, 30 02/13/2 and 45 004 1, 2, 4, 8, 03/11/2 10,12 and 15 008 hours
Propranolol HCl Propranolol HCl
Tablet Capsule (Extended Release) Tablet Tablet
03/03/2 011 07/25/2 007 06/07/2 012 01/14/2
Propylthiouracil Protriptyline HCl
Refer to USP Refer to USP
Dissolution Methods
Pseudoephedrine HCl Tablet (Extended Release) Tablet Tablet Tablet (Extended Release) Tablet (Extended Release) II (Paddle) 50 Refer to USP 008 01/14/2 008 01/15/2 010 06/10/2 009 1, 2, 4, 6, 8 06/10/2 and 12 hours 009 01/31/2 013
Pseudoephedrine HCl/Triprolidine HCl Pyridostigmine Bromide Pyridostigmine Bromide
Refer to USP Refer to USP Water 900
Quetiapine Fumarate
I (Basket, with 20 mesh)
200
Quetiapine Fumarate Quinapril HCl
Tablet Tablet
II (Paddle) 50
0.05M citric acid and 0.09 N NaOH (pH 4.8) [solution A]. At 5 hrs, pH adjusted to 6.6 by addition of 100 mL of 0.05M dibasic sodium phosphate and 0.46N NaOH [solution B] Water (deaerated) Refer to USP
900 [solution 1, 2, 4, 6, 8, A]. 1000 10, 12, 16, [final] 20, and 24 hours
900
10, 20, 30 and 45
02/18/2 004 07/25/2 007
Dissolution Methods
Quinine Sulfate Rabeprazole Sodium Capsule Tablet (Delayed II (Paddle) 100 Release) Refer to USP 700 mL 0.1 N HCl (Acid stage), after two hours add 300 mL of 0.6 M Tris buffer; adjust to pH 8.0 (Buffer stage) with 2 N HCl or 2 N NaOH . Stabilize the samples with the addition of 0.5 N NaOH 0.1% Polysorbate 80 in water Water (Deaerated) Acid stage: 700; Buffer stage: 1000 Acid stage: 120; Buffer stage: 10, 20, 30, and 45 01/14/2 008 09/22/2 011
Raloxifene HCl
Tablet
II (Paddle) 50
1000
10, 20, 30 and 45
02/18/2 004
Raltegravir Potassium
Tablet
Ramelteon Ramipril Ramipril
Tablet Capsule Tablet
II (Paddle) 100 with option to use a sinker II (Paddle) 50 II (Paddle) 50 II (Paddle) 50
900
15, 30, 45, 60 04/02/2 and 120 009
Water 0.1 N HCl 0.1 N HCl
900 500 500
10, 20, 30 and 45 10, 20, 30 and 45 5, 10, 15 and 30
04/02/2 009 02/18/2 004 09/03/2 008
Dissolution Methods
Ranitidine HCl Ranitidine HCl Ranitidine HCl Tablet Capsule Tablet (Effervescent) Tablet (Extended Release) Tablet Tablet Tablet Capsule Capsule Capsule Tablet II (Paddle) 50 II (Paddle) 50 I (Basket) 100 II (Paddle) 50 II (Paddle) 50 Refer to USP Water (deaerated) Develop a dissolution method 0.1 N HCl 900 10, 20, 30 and 45 07/25/2 007 02/18/2 004 04/08/2 010 06/03/2 008 01/29/2 010 07/25/2 007 02/18/2 004 02/18/2 004 12/15/2 009 06/18/2 007 02/25/2 004 07/21/2 011
Ranolazine
900
Rasagiline Mesylate Repaglinide Ribavirin Ribavirin Rifabutin Rifampin Rifapentine
II (Paddle) 50
0.1 N HCl Refer to USP Water (deaerated) Water (deaerated) Refer to USP Refer to USP
500
0.5, 2, 4, 8, 12, 20, and 24 hours 10, 15, 30 and 45
900 900
10, 20, 30 and 45 10, 20, 30 and 45
Rifaximin (200 mg)
Tablet
II (Paddle)
75
0.8% SLS in 900 Phosphate Buffer, pH 7.0 0.1M sodium 1000 phosphate buffer
10, 20, 30, 45, 60 and 90 10, 20, 30, 45, 60, 90
Dissolution Methods
pH 7.4 containing 0.45% Sodium Lauryl Sulfate 0.1M sodium 1000 phosphate buffer pH 7.4 containing 0.8% Sodium Lauryl Sulfate 0.5% 900 Polysorbate 20 in 0.01N HCl (pH=2.0) 0.1 N HCl 900 Water Acid stage: 0.1 N HCl; Buffer stage: Phosphate buffer, pH 6.8 Refer to USP For Risedronate Tablets: Refer to 900 Acid stage: 500; Buffer stage: 500 and 120
Rifaximin (550 mg)
Tablet
II (Paddle)
75
10, 20, 30, 45, 60, 90 and 120
07/21/2 011
Rilpivirine HCl
Tablet
II (Paddle) 75
10, 20, 30, 45 08/15/2 and 60 013
Riluzole Rimantadine HCl Risedronate Sodium
Tablet Tablet
II (Paddle) 50 II (Paddle) 50 75
Tablet (Delayed II Release) (Paddle)
10, 20, 30, 45 and 60 10, 20, 30, and 45 Acid stage: 120; Buffer Stage: 10, 15, 20, 30 and 45
02/18/2 004 01/03/2 007 01/26/2 012
Risedronate Sodium
Tablet
Risedronate Sodium/Calcium Tablet Carbonate (Copackaged)
07/01/2 010 07/01/2 010
Dissolution Methods
USP; For Calcium Carbonate Tablets: Refer to USP. Develop a dissolution method using USP IV (FlowThrough Cell), and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency 0.1N HCl 500 0.1 N HCl 500
Risperidone
Injectable
01/15/2 010
Risperidone Risperidone Ritonavir
Tablet Tablet (Orally Disintegrating) Capsule
0.1 N HCl with 900 25 mM Polyoxyethylene 10 Laurylether
10, 20, 30, 45 03/04/2 and 60 006 5, 10, 15 07/23/2 004 10, 20, 30 02/18/2 and 45 004
Dissolution Methods
Ritonavir Tablet II (Paddle) 75 (POE10LE) 60 mM 900 Polyoxyethylene 10 Laurylether (POE10LE) 0. 9 % NaCl at 500 32 C 10, 20, 30, 45, 60, 90, 120, 150 and 180 1, 2, 4, 7, 9 and 12 hours 10/28/2 010
Rivastigmine
Film, Transdermal
Rivastigmine Tartrate Rizatriptan Benzoate Rizatriptan Benzoate Roflumilast
Capsule Tablet (Orally Disintegrating) Tablet Tablet
Modified 50 USP Type VI (cylinder) II (Paddle) 50 II (Paddle) 50 II (Paddle) 50 II (Paddle) 50
06/10/2 009
Ropinirole HCl Ropinirole HCl
Tablet Tablet (Extended Release) Tablet
I (Basket)
50
II (Paddle) 100
Water (deaerated) Water (deaerated) Water (deaerated) 1.0% SDS (sodium dodecyl sulfate) in Phosphate Buffer, pH 6.8 Citrate Buffer, pH 4.0 pH 4.0 CitrateTHAM Buffer 0.01M Acetate Buffer, pH 4.0
500 900 900 1000
10, 20, 30 and 45 5, 10 and 15
01/03/2 007 02/18/2 004 5, 10, 15 and 02/18/2 30 004 5, 10, 15, 20, 08/15/2 30 and 45 013
500 500
Rosiglitazone Maleate
II (Paddle) 50
900
5, 10, 15 and 30 1, 2, 4, 6, 8, 12, 16, 20 and 24 hours 10, 20, 30 and 45
01/03/2 007 08/27/2 009 02/24/2 004
Dissolution Methods
Rosuvastatin Calcium Tablet II (Paddle) 50 0.05 M Sodium 900 Citrate Buffer pH 6.6 0.05 Phosphate 900 Buffer, pH 4.5 at 32C 2.0% SDS 900 (sodium dodecyl sulfate) in water Refer to USP 0.1 N HCl Citrate buffer (pH 3.0) Refer to USP 0.1 N HCl 10, 20, 30 and 45 15, 30, 60, 90, 120, 150 and 180 5, 10, 15, 20 and 30 11/10/2 010 07/15/2 009
Rotigotine
Transdermal
Rufinamide
Suspension
Paddle 50 over Disk (Apparatus 5) II (Paddle) 50
08/15/2 013
Rufinamide Sapropterin Dihydrochloride Saquinavir Mesylate Saquinavir Mesylate Saxagliptin HCl Scopolamine
Tablet Tablet Tablet Capsule Tablet Transdermal II (Paddle) 50 Reciprocati ng disk (Apparatus 7) Paddle over Disk (Apparatus II (Paddle) 50 II (Paddle) 50
Selegiline (20 mg/20 cm2 and Transdermal 30 mg/30 cm2)
Stroke depth: Distilled Water 2-3 cm; 30-60 cycles per minute 50 0.1 M Phosphate buffer,
08/15/2 013 900 5, 10, 15 and 10/06/2 20 008 900 10, 20 , 30 09/13/2 and 45 007 09/13/2 007 900 5, 10, 15, 20, 08/15/2 30 and 45 013 25 150 mm 1, 2, 4, 6, 12, 07/15/2 test-tubes 18, 24, 36, 009 containing 20 48, and 72 mL hours 500 1, 2, 4, 8, 12, 07/15/2 16, 20 and 24 009 hours
Dissolution Methods
5) Selegiline (40 mg/40 cm2) Transdermal Rotating 50 Cylinder (Apparatus 6) I (Basket) 50 monobasic, pH 5 at 32C 0.1 M 1000 Phosphate buffer, monobasic, pH 5 at 32C Water 500 0.05 M Sodium 900 Acetate Buffer, pH 4.5 Disintegration Testing in 0.1 N HCl as per USP <701> Disintegration Testing in 0.1 N HCl as per USP <701> Disintegration Testing in 0.1 N HCl as per USP <701> 0.05 M Acetate 500 Buffer, pH 4.0 0.01 N HCl 900 1, 2, 4, 8, 12, 07/15/2 16, 20 and 24 009 hours
Selegiline HCl Sertraline HCl
Tablet (Orally Disintegrating) Tablet
II (Paddle) 75
5, 10, 15 and 20 10, 20, 30 and 45
10/06/2 008 02/20/2 004 10/06/2 008
Sevelamer Carbonate
Tablet
Sevelamer HCl
Capsule
04/09/2 008
Sevelamer HCl
Tablet
04/09/2 008
Sibutramine HCl Sildenafil Citrate
Capsule Tablet
10, 20, 30, 45 02/25/2 and 60 004 5, 10, 15 and 03/04/2
Dissolution Methods
Silodosin Simvastatin Simvastatin Sirolimus Capsule Tablet Tablet (Orally Disintegrating) Tablet II (Paddle) 75 Basket (20 120 mesh) I (Basket) 100 II (Paddle) 50 with sinker 0.1 N HCl Refer to USP 0.15% SDS Buffer, pH 6.8 0.4% SLS in water Water 900 500 900 30 5, 10, 15, 20 and 30 006 06/07/2 012 06/18/2 007 5, 10, 15 and 09/03/2 30 008 10, 20, 30, 03/14/2 45, 60 and 007 120 5, 10, 15, 20 07/01/2 and 30 010 5, 10, 15, 20, 10/31/2 30, and 45 013
Sitagliptin Phosphate Sitagliptin Phosphate/Simvastatin
Tablet Tablet
900
Sodium Iodide I-123 Sodium Phenylbutyrate
Capsule
II (Paddle) 100 with stainless steel stationary quadrangul ar hanging basket I (Basket) 100
10 mM Sodium 900 phosphate buffer containing 1% Tween 80 with 50 g/mL Butylated hydroxyanisole Water (deaerated) Simulated Intestinal Fluid Water (deionized) 500 900 900
Powder for oral II (Paddle) 75 II (Paddle) 100
Sodium Phosphate Dibasic Tablet Anhydrous/Sodium Phosphate Monobasic Monohydrate
5, 10, 15 and 30 15, 30, 45, 60 and 90 20, 30, 45, 60 and 90
07/14/2 008 04/02/2 009 01/15/2 010
Dissolution Methods
Solifenacin Succinate Sorafenib Tosylate Spironolactone Stavudine Succimer Tablet Tablet Tablet Capsule Capsule II (Paddle) 50 II (Paddle) 50 II (Paddle) 75 Water 0.1M HCl with 1% SDS Refer to USP Refer to USP 0.01 N 900 Phosphoric Acid 0.1N HCl/0.067 900 M KCl, pH 1.0 0.1 N HCl/0.067 900 M KCl, pH 1.0 Refer to USP Refer to USP II (Paddle) 50 1 mL of 0.2 N HCl in water Refer to USP Refer to USP 900 10, 20, 30, 45, 60 and 90 10, 20, 30, 45, 60 and 90 10, 20, 30 and 45 15, 30, 45, 60, 180, 240 and 480 900 900 10, 15, 30 and 45 5, 10, 15, 20 and 30 02/19/2 008 06/10/2 009 04/15/2 008 06/18/2 007 02/20/2 004 03/04/2 006 04/02/2 009 07/14/2 008 01/14/2 008 02/25/2 004 12/15/2 009 12/15/2 009
Sucralfate Sucralfate
Suspension Tablet
Sulfadiazine
Tablet
Sulfamethoxazole/Trimethopri Tablet m Sulfamethoxazole/Trimethopri Suspension m Sulfasalazine Sulfasalazine Tablet Tablet (Delayed Release)
Dissolution Methods
Sulfisoxazole Acetyl Sumatriptan Succinate Sunitinib Malate Tacrolimus Oral Suspension II (Paddle) 30 (Pediatric) Tablet II (Paddle) 30 Capsule Capsule II (Paddle) 50 II (Paddle) 50 1% SLS in 0.1N 900 HCl 0.01 M HCl 900 0.1 N HCl 900 15, 30, 45, 60 and 90 5, 10, 15 and 30 10, 15, 30 and 45 30, 60, 90 and 120 08/17/2 006 03/04/2 006 10/30/2 009 02/20/2 004
Tadalafil Tamoxifen Citrate Tamsulosin HCl
Tablet Tablet Capsule
II (Paddle) 50
Hydroxypropyl 900 Cellulose Solution (1 in 20,000). Adjust to pH 4.5 by Phosphoric Acid 0.5% Sodium 1000 Lauryl Sulfate Refer to USP 0-2 hours: 500 0.003% polysorbate 80, pH 1.2 2-8 hours: phosphate buffer, pH 7.2 0.1 N HCl 900 0.05 M Phosphate 900
10, 20, 30 and 45
II (Paddle) 100
01/26/2 006 04/02/2 009 1, 2, 3, 6, 8, 03/26/2 and 10 hours 007
Tapentadol HCl Tapentadol HCl
Tablet Tablet (Extended
I (Basket)
75
II (Paddle) 100 with
10, 20, 30, 45 and 60 0.5, 1, 2, 3, 4, 6, 8, 10 and
10/28/2 010 10/31/2 013
Dissolution Methods
Release) sinker Buffer of pH 6.8, Simulated intestinal fluid (without enzyme) 1% SLS in 900 Water 0.1 N HCl 900 0.1 N HCl Refer to USP Refer to USP I (Basket) 100 Water 500 (for 5 mg); 900 ml (for other strengths) 900 900 10, 20, 30, and 45 900 12 hours
Telaprevir Telbivudine Telithromycin Telmisartan Temazepam Temozolomide
Tablet Tablet Tablet Tablet Capsule Capsule
II 50 (Paddle) II (Paddle) 50 II (Paddle) 50
5, 10, 15, 20 and 30 15, 30 and 45 10, 20, 30 and 45
05/09/2 013 04/02/2 009 01/03/2 007 01/05/2 012 01/14/2 008 08/11/2 008
Tenofovir Disoproxil Fumarate Tablet Tenofovir Disoproxil Fumarate Powder for Oral Terazosin HCl Terazosin HCl Tablet Capsule
0.1 N HCl 0.2% polysorbate 80 in 0.01 M HCl Water (deaerated) Water
900 900
10, 20, 30, and 45 10, 20, 30, 45, 60 and 75 10, 20, 30, 45 and 60 10, 20, 30,
01/03/2 007 01/31/2 013 02/20/2 004 02/20/2
Dissolution Methods
(deaerated) Terbinafine HCl Tablet II (Paddle) 50 Citrate Buffer, 500 pH 3.0 adjusted with HCl 0.12 N HCl with 900 1% SLS 45, 60 and 90 10, 20, 30 and 45 15, 30, 45, 60, 90, 120 and 150 004 02/20/2 004 10/08/2 009
Terconazole
Suppository (Vaginal)
Testosterone
Buccal Tablet (Extended Release) Pellet Implant
I (with 100 Palmieri type basket) II (Paddle, 60 may use sinker)
Testosterone
Testosterone
Film, Transdermal (Extended Release)
V (Paddle 50 over disk). Paddle 25 mm above the film on the disk.
Tetrabenazine
Tablet
II (paddle) 50
1% sodium 1000 dodecyl sulfate in double distilled water Develop a dissolution method 0.1 M sodium 900 chloride containing 2.5% (v/v) of Tween 40 at 32 0.5C. Delivery surface faces upwards towards the media. 0.1 N HCl 900
1, 2, 4, 6, 10, 01/03/2 12 and 24 007 hours 11/25/2 008 1, 3, 5, 7, 11, 06/30/2 16, 20 and 24 011 hours
5, 10, 15, 30 and 45
09/01/2 011
Dissolution Methods
Tetracycline HCl Tetracycline HCl Thalidomide Tablet Capsule Capsule II (Paddle) 100 Refer to USP Refer to USP 1.5% (w/v) SLS 900 (pH 3.0, adj w/ HCl) Refer to USP 900 01/29/2 010 06/24/2 010 10, 20, 30, 60 03/04/2 and 90 006 10/06/2 008 1, 4, 8, 12 hours 10/06/2 008
Theophylline
Capsule (Extended Release) Theophylline (100 mg and 200 Tablet mg) (Extended Release)
II (Paddle) 50
Theophylline (300 mg and 450 Tablet mg) (Extended Release)
II (Paddle) 50
SGF without 900 Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing SGF without 900 Enzyme, pH 1.2 during 1st hour. Phosphate Buffer at pH 7.5 from end of hour 1 through the duration of testing
1, 4, 8, 12 hours
10/06/2 008
Dissolution Methods
Theophylline (600 mg and 400 Tablet mg) (Extended Release) I (Basket) 100 SGF without 900 enzyme, pH 1.2 during 1st hour. SIF without enzyme from end of hour 1 through the duration of the testing Refer to USP Water Water (deaerated) Refer to USP 900 900 1, 2, 4, 8, 12 10/06/2 and 24 hours 008
Thioguanine Tiagabine HCl Ticlopidine HCl Timolol Maleate Tinidazole Tipranavir
Tablet Tablet Tablet Tablet Tablet Capsule I (Basket) 100 II (Paddle) 50 II (Paddle) 50
II (Paddle) 50
Tizanidine HCl Tizanidine HCl Tolcapone
Capsule Tablet Tablet
Water 900 (Deaerated) 0.05 M 900 phosphate buffer pH 6.8 0.01 N HCl 500 0.1 N HCl Refer to USP 500
07/15/2 009 5, 10, 15, 20 01/03/2 and 30 007 10, 20, 30, 45 02/19/2 and 60 004 07/31/2 013 10, 20, 30 01/03/2 and 45 007 15, 30, 45 12/03/2 and 60 007 5, 10, 15 and 30 5, 10, 15 and 30 02/20/2 004 02/20/2 004 05/09/2
Dissolution Methods
Tolterodine Tartrate Tablet II (Paddle) 50 SGF without enzymes, pH 1.2 Phosphate buffer (pH 6.8) 900 013 5, 10, 15 and 02/20/2 30 004 1, 3, 7 hours 06/18/2 007 02/19/2 004 02/19/2 004 04/27/2 009 02/20/2 004 02/20/2 004 02/19/2 004 01/03/2 007 02/20/2 004 12/19/2 008
Tolterodine Tartrate
Topiramate Topiramate Topotecan HCl
Capsule (Extended Release) Capsule (Sprinkle) Tablet Capsule
I (Basket)
100
900
Toremifene Citrate Torsemide Tramadol HCl Tramadol HCl
Tablet Tablet Tablet Tablet (Extended Release) Tablet Tablet (Extended
II (Paddle) 50 II (Paddle) 50 I (Basket) I (Basket) 100 75
Water 900 (deaerated) Water 900 (deaerated) Acetate Buffer 500 with 0.15% SDS, pH 4.5 0.02 N HCl 1000 0.1 N HCl 0.1 N HCl 0.1 N HCl 900 900 900
10, 20, 30, 45 and 60 5, 10, 20 and 30 5, 10, 20, 30 and 45 10, 20, 30 and 45 5, 10, 15 and 30 10, 20, 30 and 45 2, 4, 8, 10 and 16 hours 10, 20, 30, 45 and 60 For Trandolapril:
Trandolapril Trandolapril/Verapamil HCl
Water 500 (deaerated) For Trandolapril: For Water; For Trandolapril:
Dissolution Methods
Release) Verapamil: 0-1 500; For hour Gastric Verapamil: Fluid w/o Pepsin 900 pH=1.2, 1-8 hour Intestinal Fluid w/o Pancreatin Water 900 5, 10, 20, 30 and 45; For Verapamil: 1, 2, 3.5, 5 and 8 hours 15, 30, 45, 60, 90 and 120 12/23/2 010
Tranexamic Acid
Tablet
II (Paddle
50
Tranylcypromine Sulfate Trazodone HCl Trazodone HCl
Tablet Tablet Tablet (Extended Release) Capsule II (Paddle) 50
Refer to USP Refer to USP Water 900
Tretinoin
I (Basket)
100
Triamcinolone Acetonide
Injectable Suspension
0.5% solid 900 Lauryldimethyla mine-oxide (LDAO) in 0.05M Phosphate Buffer, pH 7.8 Develop a dissolution method using USP IV (FlowThrough Cell),
10/31/2 013 12/15/2 009 1, 2, 3, 5, 8, 06/30/2 10, 12, 16, 20 011 and 24 hours 10, 15, 20, 30 08/05/2 and 45 010
01/15/2 010
Dissolution Methods
and, if applicable, Apparatus II (Paddle) or any other appropriate method, for comparative evaluation by the Agency Refer to USP Refer to USP Refer to USP I (Basket) 100 Water (deaerated) 1000 10, 20, 30, 45, 60 and 90 1, 6, 12, 24, 48 and 72 hours
Triamterene Trientine HCl Trimethoprim Trimipramine Maleate
Capsule Capsule Tablet Capsule
06/18/2 007 07/31/2 013 01/29/2 010 03/04/2 006 07/14/2 008
Triptorelin Pamoate
Injectable Suspension
II (Paddle) 200
Trospium Chloride
Tablet
II (Paddle) 50
Water-Methanol 500 (95:5); Reconstitute vial in 2 mL Water for Injection, add to 500 mL medium at 37C 0.1 N HCl 1000
10, 20, 30 and 45
12/03/2 007
Dissolution Methods
Trospium Chloride Capsule (Extended Release) II (Paddle) 50 with sinker 0.1 N HCl, pH 0-2 hrs: 750 1.1 for 2 hrs and ml, After 2 then add 200 mL hrs: 950 ml. of 0.1 N NaOH in 200 mM Phosphate Buffer. Adjust pH to 7.5 using 2 N HCl and/or 2N NaOH 0.1N HCl 900 Refer to USP Refer to USP II (Paddle) 50 II (Paddle) 50 0.1 N HCl 0.1 N HCl Refer to USP II (Paddle) 50 0.067 M Phosphate Buffer, pH 6.8 Refer to USP 1000 900 900 2, 3, 4, 6, 8, 12 and 16 hours 07/15/2 010
Ulipristal Acetate Ursodiol Ursodiol Valacyclovir Hydrochloride Valganciclovir HCl Valproic Acid Valsartan (Tab & Cap)
Tablet Tablet Capsules Tablet Tablet Capsule Tablet
II (Paddle) 50
5, 10, 15, 20 and 30
01/31/2 013 04/15/2 008 07/21/2 009 10, 20, 30, 45 08/27/2 and 60 009 10,15, 30, 45, 06/18/2 60 007 12/15/2 009 10, 20, 30 12/13/2 and 45 004 01/14/2 008
Vancomycin hydrochloride
Capsule
Dissolution Methods
Vardenafil HCl Varenicline Tartrate Venlafaxine HCl Venlafaxine HCl Tablet Tablet Tablet Capsule (Extended Release) Tablet II (Paddle) 50 I (Basket) 100 0.1 N HCl 0.01N HCl Water (deaerated) Water 900 500 900 900 5, 10, 15 and 30 5, 10, 15 and 30 5, 10, 15 and 30 2, 4, 8, 12 and 20 hours 12/20/2 005 12/03/2 007 02/19/2 004 01/03/2 007 11/04/2 008 06/24/2 010 1000 1, 4, 8, 11, 01/03/2 and 24 hours 007
Verapamil HCl Verapamil HCl
Refer to USP Refer to USP
Tablet (Extended Release) Verapamil HCl (100, 200, 300 Capsule mg) (Extended Release) Verapamil HCl (120, 180, 240, Capsule 360 mg) (Sustained Release) Vilazodone HCl Voriconazole Voriconazole Tablet Suspension Tablet
I (Basket)
75
I (Basket)
75
Water, pH 3.0 (adjusted with 0.1 N or 2 N HCl) Water, pH 3.0 (adjusted with 0.1 N or 2 N HCl) 0.1% v/v Acetic acid (pH 3.1) 0.1 N HCl 0.1 N HCl
1000
1, 4, 8, 11, 01/03/2 and 24 hours 007
1000 900 900
10, 20, 30, and 45 10, 20, 30 and 45 10, 20, 30
01/26/2 012 01/03/2 007 11/25/2
Dissolution Methods
Vorinostat Warfarin Sodium Zafirlukast Capsule Tablet Tablet II (Paddle) 50 II (Paddle) 100 with sinker 2% Tween 80 in 900 Water Refer to USP 1% w/v Aqueous 1000 Sodium Dodecyl Sulfate Refer to USP 900 Deionized Water Refer to USP Refer to USP II (Paddle) 50 II (Paddle) 75 with sinker II (Paddle) 50 II (Paddle) 75 0.05 M SLS in 900 water 0.1 M SDS 900 (sodium dodecyl sulfate) in water 0.1 N HCl 900 Tier I: 0.05 M Na 900 phosphate buffer, pH 7.5 + 2% SDS (w/w) 900 and 45 5, 15, 30, 45 and 60 008 09/03/2 008 01/29/2 010 10/09/2 007
10. 30, 30 and 45
Zalcitabine Zaleplon Zidovudine Zidovudine Zileuton Zileuton
Tablet Capsule Tablet Capsule Tablet Tablet (Extended Release) Capsule Capsule II (Paddle) 75
Zinc Acetate Ziprasidone HCl
02/19/2 008 5, 10, 20, and 01/03/2 30 007 07/25/2 007 06/18/2 007 10, 20, 30, 45 02/19/2 and 60 004 1, 2, 4, 6, 8, 08/15/2 10 and 12 013 hours 10, 20, 30 02/19/2 and 45 004 10, 20, 30, 45 03/04/2 and 60 006
Dissolution Methods
Tier II: 0.05 M Na phosphate buffer, pH 7.5 (700ml) + 1% pancreatin. After 15 min. incubation, add 200 mL of phosphate buffer containg 9% SDS 0.1 N HCl 500 0.1N HCl Phosphate buffer, pH 6.8 Refer to USP 500 900
Zolmitriptan Zolmitriptan Zolpidem Tartrate Zolpidem Tartrate
Tablet Orally Disintegrating) Tablet Tablet (Sublingual) Tablet (Extended Release) Tablet Capsule
5, 10, 15, 20 and 30 5, 10, 15, 20 and 30 1, 3, 5, 7, 10 and 15
06/18/2 007 07/21/2 009 09/02/2 010 01/05/2 012 02/19/2 004 01/03/2 007
Zolpidem Tartrate Zonisamide
0.01 N HCl, pH 2.0 Water (deaerated)
900 900
5, 10, 15 and 30 10, 20, 30 and 45
Dissolution Methods

Méthodes de Dissolution FDA

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Dissolution Methods

Recommended Sampling Date Times Updated (minutes)

Abacavir Sulfate Abacavir Sulfate/Lamivudine

II (Paddle) 75 II (Paddle) 75 II (Paddle) 75

0.1 N HCl 0.1 N HCl 0.1 N HCl

900 900 900

Abacavir Tablet Sulfate/Lamivudine/Zidovudin e Abiraterone Acetate Tablet

03/22/2 006 01/03/2 007 01/03/2 007

Tablet (Delayed I (Basket) Release)

10, 20, 30, 45 02/28/2 and 60 013

900 900 900

Acetaminophen/Pentazocine Tablet HCl Acetaminophen/Propoxyphen Tablet

Acetazolamide Acetazolomide Acitretin

0.01 N HCl Refer to USP

Albuterol Sulfate Alendronate Sodium Alendronate Sodium/Cholecalciferol

Tablet (Extended Release) Tablet

Tablet (Orally Disintegrating)

Alprazolam Altretamine Alvimopan Amantadine HCl Amantadine HCl Ambrisentan

Tablet (Extended Release) Tablet Capsule Capsule Tablet Capsule Tablet

Amiodarone HCl (Test 1)

Amiodarone HCl (Test 2)

Amitriptyline HCl Amlodipine Besylate Amlodipine Besylate

Amlodipine Besylate/Atorvastatin Calcium Amlodipine Capsule Besylate/Benazepril HCl Amlodipine Tablet

Telmisartan: 900; Amlodipine: 500

Amlodipine Besylate/Valsartan Amoxicillin

Tablet Tablet (Extended Release)

07/21/2 011 10/21/2 010

For Oral II (Paddle) 50 Suspension Amoxicillin/Clarithromycin/Lan Capsule/Tablet/ soprazole Capsule (Copackage)

Amoxicillin/Clarithromycin/Om Capsule/Tablet/ eprazole Capsule (Copackage)

Capsule (Extended Release)

0.5, 1, 2, 3, and 4 hours

1, 2, 3, 4, and 08/17/2 6 hours 006

II (Paddle) 25 II (Paddle) 50 I (Basket) 100

900 900 900 900 900

Tablet (Orally Disintegrating) Tablet

10, 20, 30 and 45 10, 20, 30 and 45

08/11/2 008 01/14/2 008

Aspirin/Butalbital/Caffeine/Co Capsule deine Phosphate Aspirin/Caffeine/Orphenadrine Tablet Citrate Aspirin/Dipyridamole Capsule

Aspirin/Hydrocodone Bitartrate Aspirin/Meprobamate

Aspirin/Oxycodone HCl Atazanavir Sulfate

Oral Suspension Tablet II (Paddle) 50 with PEAK vessels

07/21/2 009 900 15, 30, 45 and 60 08/17/2 006

10, 20, 30, and 45

01/15/2 004 09/03/2

Suspension (Extended Release) Tablet

04/15/2 008 01/14/2 008 08/17/2 006 07/14/2 008

Oral Suspension Tablet (Orally Disintegrating) Tablet Tablet

900 500 mL (10 mg) or 1000 mL (20mg)

Baclofen Balsalazide Disodium

II (Paddle) 50 I (Basket) IV (Flow through cell) 100 Flow @ 8 mL/min

Bethanechol Chloride Bexarotene

10/06/2 008 08/17/2 006

Bismuth Subcitrate Capsule Potassium/Metronidazole/Tetr acycline HCl

10, 20, 30, 45 and 60 5, 15, 20, 30 and 45

12/15/2 005 10/06/2 008

Tablet Ophthalmic Suspension

Bromocriptine Mesylate Budesonide

Tablet Capsule II (Paddle) 75 with sinker

15, 30, 45 and 60

09/02/2 010 09/01/2 011

Tablet Film, Transdermal VI (Cylinder) 50

Buprenorphine HCl/Naloxone Film HCl (Sublingual)

1, 3, 5, 7.5, 10, 15 and 20